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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K953070
Device Name WOUNDFOAM 4 X 4
Applicant
TRINITY LABORATORIES, INC.
201 KILEY DR.
P.O. BOX 1818
SALISBURY,  MD  21802
Applicant Contact PARTHA BASUMALLIK
Correspondent
TRINITY LABORATORIES, INC.
201 KILEY DR.
P.O. BOX 1818
SALISBURY,  MD  21802
Correspondent Contact PARTHA BASUMALLIK
Regulation Number880.5090
Classification Product Code
KMF  
Date Received06/30/1995
Decision Date 09/08/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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