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U.S. FDA Medical Device Blow Bottle Requirements

FDA Medical Device Definition: A blow bottle is a device that is intended for medical purposes to induce a forced expiration from a patient. The patient blows into the device to move a column of water from one bottle to another.

Registrar Corp assists Blow Bottle companies with:

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