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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 K925545
Device Name SKINTEMP, MODIFICATION
Applicant
Biocore
7420 Falcon St.
Topeka,  KS  66610
Applicant Contact MANOJ K JAIN
Correspondent
Biocore
7420 Falcon St.
Topeka,  KS  66610
Correspondent Contact MANOJ K JAIN
Classification Product Code
KGN  
Date Received10/15/1992
Decision Date 02/23/1993
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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