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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 K893647
Device Name COPOLYESTER FILM DRESSING
Applicant
Tri-State Hospital Supply Corp.
301 Catrell Dr.
P.O. Box 170
Howell,  MI  48843
Applicant Contact GEORGE J PLUTA
Correspondent
Tri-State Hospital Supply Corp.
301 Catrell Dr.
P.O. Box 170
Howell,  MI  48843
Correspondent Contact GEORGE J PLUTA
Classification Product Code
KGN  
Date Received05/15/1989
Decision Date 10/16/1989
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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