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U.S. FDA Medical Device Leaded Apron Requirements

FDA Medical Device Definition: A personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation. This generic type of device may include articles of clothing, furniture, and movable or stationary structures.

Registrar Corp assists Leaded Apron companies with:

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