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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing With Animal-Derived Material(S)
510(k) Number K061494
Device Name DERMADAPT WOUND DRESSING
Applicant
Pegasus Biologics, Inc.
6 Jenner, Suite 150
Irvine,  CA  92618
Applicant Contact PAMELA MISAJON
Correspondent
Pegasus Biologics, Inc.
6 Jenner, Suite 150
Irvine,  CA  92618
Correspondent Contact PAMELA MISAJON
Classification Product Code
KGN  
Date Received05/31/2006
Decision Date 09/21/2006
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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