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FDA 510(k)

DERMABIOSAFE

K-Number: K080298 · 2008-08-05

ApplicantComplete Product Resources
Decision Date2008-08-05
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DERMABIOSAFE is the device name listed in this FDA 510(k) record. The listed applicant is Complete Product Resources. It received FDA 510(k) clearance on 2008-08-05 under 510(k) number K080298. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DERMABIOSAFE?

DERMABIOSAFE is a medical device that received FDA 510(k) clearance on 2008-08-05. The listed applicant is Complete Product Resources. The 510(k) number is K080298.

When did DERMABIOSAFE receive FDA 510(k) clearance?

DERMABIOSAFE received FDA 510(k) clearance on 2008-08-05, under 510(k) number K080298.

Who is the listed applicant for DERMABIOSAFE?

The FDA 510(k) record lists Complete Product Resources as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DERMABIOSAFE?

The FDA product code for DERMABIOSAFE is GXY.

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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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