FDA 510(k)

ABSORBATACK AND APPLICATOR

K-Number: K071061 · 2007-05-16

Decision Date2007-05-16

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ABSORBATACK AND APPLICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Sorbx, LLC. It received FDA 510(k) clearance on 2007-05-16 under 510(k) number K071061. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABSORBATACK AND APPLICATOR?

ABSORBATACK AND APPLICATOR is a medical device that received FDA 510(k) clearance on 2007-05-16. The listed applicant is Sorbx, LLC. The 510(k) number is K071061.

When did ABSORBATACK AND APPLICATOR receive FDA 510(k) clearance?

ABSORBATACK AND APPLICATOR received FDA 510(k) clearance on 2007-05-16, under 510(k) number K071061.

Who is the listed applicant for ABSORBATACK AND APPLICATOR?

The FDA 510(k) record lists Sorbx, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABSORBATACK AND APPLICATOR?

The FDA product code for ABSORBATACK AND APPLICATOR is GDW.

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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.