U.S. FDA Medical Device Circumcision Bell 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.
Registrar Corp assists Circumcision Bell companies with:
FDA Circumcision Bell Establishment Registration
FDA Circumcision Bell Listing
FDA Circumcision Bell Label Requirements and Exceptions
FDA Circumcision Bell Import Information
FDA Circumcision Bell Detentions (Circumcision Bell Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Circumcision Bell Manufacturers (Circumcision Bell Suppliers)
- Circumcision Bell Distributors
- Circumcision Bell Processors
- Circumcision Bell Repackers
- Circumcision Bell Relabelers
- Circumcision Bell Exporters
- Circumcision Bell Importers
For more information about Circumcision Bell 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.