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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bandage, liquid
510(k) Number K042955
Device Name CUTICOVER SKIN BARRIER DEVICE
Applicant
D & D HOLDINGS, LLC
10 WYNSTONE
NASHVILLE,  TN  37215
Applicant Contact MARK CITRON
Correspondent
D & D HOLDINGS, LLC
10 WYNSTONE
NASHVILLE,  TN  37215
Correspondent Contact MARK CITRON
Regulation Number880.5090
Classification Product Code
KMF  
Date Received10/26/2004
Decision Date 06/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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