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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 K023778
Device Name DRESSSKIN
Applicant
TEI BIOSCIENCES INC.
7 ELKINS ST.
BOSTON,  MA  02127
Applicant Contact KENNETH JAMES
Correspondent
TEI BIOSCIENCES INC.
7 ELKINS ST.
BOSTON,  MA  02127
Correspondent Contact KENNETH JAMES
Classification Product Code
KGN  
Date Received11/12/2002
Decision Date 09/29/2003
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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