FDA 510(k) Application Details - K200168

Device Classification Name

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510(K) Number K200168
Device Name Dermapose Access
Applicant Puregraft LLC
420 Stevens Avenue, Suite 220
Solana Beach, CA 92075 US
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Contact Olivia Kim
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Regulation Number

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Classification Product Code QPB
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Date Received 01/23/2020
Decision Date 04/22/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
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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