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Filing a MAF for Arcom Polyethylene with the U.S. FDA

Filing a medical device master file (MAF) for Arcom Polyethylene can be a useful mechanism to market your Arcom Polyethylene to the U.S. Medical Device Industry. Typical Arcom Polyethylene producers who have filed a MAF for Arcom Polyethylene include:


Registrar Corp can help you to properly prepare and submit your Arcom Polyethylene MAF to FDA.

As your Agent, Registrar Corp will perform the following administrative functions:

  - Ensure administrative accuracy of your Arcom Polyethylene MAF
  - Format, assemble and deliver your Arcom Polyethylene MAF to FDA
  - Assist with preparing letters of authorization regarding your Arcom Polyethylene MAF
 - Provide changes, additions and maintenance of your Arcom Polyethylene MAF
  - Respond to issues relating to ownership of your Arcom Polyethylene MAF
  - Assist with submission of responses to FDA concerning your Arcom Polyethylene MAF

For more information about filing a MAF for Arcom Polyethylene, 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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