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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K942014
Device Name STERILE WATER WET DRESSING
Applicant
Trinity Laboratories, Inc.
201 Kiley Dr.
Salisbury,  MD  21801
Applicant Contact PARTHA BASUMALLIK
Correspondent
Trinity Laboratories, Inc.
201 Kiley Dr.
Salisbury,  MD  21801
Correspondent Contact PARTHA BASUMALLIK
Classification Product Code
MGF
Subsequent Product Code
EFQ  
Date Received04/26/1994
Decision Date 05/27/1994
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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