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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 K002443
Device Name COLLAGEN WOUND DRESSING
Applicant
Oasis Research, LLC
514 S Vermont Ave.
Glendora,  CA  91741
Applicant Contact JAMES CHRISTENSEN
Correspondent
Oasis Research, LLC
514 S Vermont Ave.
Glendora,  CA  91741
Correspondent Contact JAMES CHRISTENSEN
Classification Product Code
KGN  
Date Received08/09/2000
Decision Date 10/18/2000
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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