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U.S. FDA Medical Device Hot or Cold Disposable Pack Requirements: Hot or Cold Disposable Pack

FDA Medical Device Definition: A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces

Registrar Corp assists Hot or Cold Disposable Pack companies with:

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




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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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