FDA 510(k) Application Details - K220566

Device Classification Name Dressing, Wound, Drug

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510(K) Number K220566
Device Name Dressing, Wound, Drug
Applicant KOAG LLC
790 Rarity Bay Pkwy
Vonore, TN 37885 US
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Contact David Lang
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 02/28/2022
Decision Date 07/29/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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