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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K921204
Device Name DELUXE WOUND CLOSURE TRAY, STERILE, DISPOSABLE
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
Regulation Number878.4370
Classification Product Code
KKX  
Date Received03/12/1992
Decision Date 08/13/1992
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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