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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 K882590
Device Name VIADERM
Applicant
Applied Biomedical Sciences
320 Golden Shore Dr.
Suite 300
Long Beach,  CA  90802
Applicant Contact SHERYL OSBORNE
Correspondent
Applied Biomedical Sciences
320 Golden Shore Dr.
Suite 300
Long Beach,  CA  90802
Correspondent Contact SHERYL OSBORNE
Classification Product Code
KGN  
Date Received06/23/1988
Decision Date 10/07/1988
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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