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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 K111382
Device Name CELVER
Applicant
Cellulose Concepts, LLC
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact MARIA F GRIFFIN
Correspondent
Cellulose Concepts, LLC
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact MARIA F GRIFFIN
Classification Product Code
FRO  
Date Received05/17/2011
Decision Date 05/31/2012
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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