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FDA 510(k)

PROCEL BURN COVER/PROCEL BURN TREATMENT COVER

K-Number: K943280 · 1994-08-18

ApplicantW.L. Gore & Company, GmbH
Decision Date1994-08-18
Product CodeMGP
DecisionSubstantially Equivalent for Some Indications

Device Summary

PROCEL BURN COVER/PROCEL BURN TREATMENT COVER is the device name listed in this FDA 510(k) record. The listed applicant is W.L. Gore & Company, GmbH. It received FDA 510(k) clearance on 1994-08-18 under 510(k) number K943280. The device is classified under product code MGP. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the PROCEL BURN COVER/PROCEL BURN TREATMENT COVER?

PROCEL BURN COVER/PROCEL BURN TREATMENT COVER is a medical device that received FDA 510(k) clearance on 1994-08-18. The listed applicant is W.L. Gore & Company, GmbH. The 510(k) number is K943280.

When did PROCEL BURN COVER/PROCEL BURN TREATMENT COVER receive FDA 510(k) clearance?

PROCEL BURN COVER/PROCEL BURN TREATMENT COVER received FDA 510(k) clearance on 1994-08-18, under 510(k) number K943280.

Who is the listed applicant for PROCEL BURN COVER/PROCEL BURN TREATMENT COVER?

The FDA 510(k) record lists W.L. Gore & Company, GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROCEL BURN COVER/PROCEL BURN TREATMENT COVER?

The FDA product code for PROCEL BURN COVER/PROCEL BURN TREATMENT COVER is MGP.

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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.

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