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U.S. FDA Medical Device Lead Syringe Holder 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 Lead Syringe Holder companies with:

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