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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K153678
Device Name PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove
Applicant
Permeaderm, Inc.
2905 Segovia Way
Carlsbad,  CA  92009
Applicant Contact AUBREY WOODROOF
Correspondent
Permeaderm, Inc.
2905 Segovia Way
Carlsbad,  CA  92009
Correspondent Contact AUBREY WOODROOF
Classification Product Code
FRO  
Date Received12/21/2015
Decision Date 08/08/2016
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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