FDA 510(k)

FITPACK

K-Number: K060037 · 2006-07-25

Decision Date2006-07-25

Product CodeMMK

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

FITPACK is the device name listed in this FDA 510(k) record. The listed applicant is Asp Plastics Pty , Ltd.. It received FDA 510(k) clearance on 2006-07-25 under 510(k) number K060037. The device is classified under product code MMK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FITPACK?

FITPACK is a medical device that received FDA 510(k) clearance on 2006-07-25. The listed applicant is Asp Plastics Pty , Ltd.. The 510(k) number is K060037.

When did FITPACK receive FDA 510(k) clearance?

FITPACK received FDA 510(k) clearance on 2006-07-25, under 510(k) number K060037.

Who is the listed applicant for FITPACK?

The FDA 510(k) record lists Asp Plastics Pty , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FITPACK?

The FDA product code for FITPACK is MMK.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.