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U.S. FDA Medical Device Chemiluminescent Light Source Requirements


FDA Medical Device Definition: An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:

Registrar Corp assists Chemiluminescent Light Source companies with:

  • FDA Chemiluminescent Light Source Establishment Registration
  • FDA Chemiluminescent Light Source Listing
  • FDA Chemiluminescent Light Source Label Requirements and Exceptions
  • FDA Chemiluminescent Light Source Import Information
  • FDA Chemiluminescent Light Source Detentions (Chemiluminescent Light Source Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Chemiluminescent Light Source Manufacturers (Chemiluminescent Light Source Suppliers)
       - Chemiluminescent Light Source Distributors
       - Chemiluminescent Light Source Processors
       - Chemiluminescent Light Source Repackers
       - Chemiluminescent Light Source Relabelers
       - Chemiluminescent Light Source Exporters
       - Chemiluminescent Light Source Importers
For more information about Chemiluminescent Light Source Medical Devices, simply click below:






 
U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.


Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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