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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 K920518
Device Name E.R. SUTURE TRAY, STERILE, DISPOSABLE
Applicant
Trinity Laboratories, Inc.
P.O. Box 4458
201 Kiley Dr.
Salisbury,  MD  21803
Applicant Contact PARTHA BASUMALLIK
Correspondent
Trinity Laboratories, Inc.
P.O. Box 4458
201 Kiley Dr.
Salisbury,  MD  21803
Correspondent Contact PARTHA BASUMALLIK
Regulation Number878.4370
Classification Product Code
KKX  
Date Received02/04/1992
Decision Date 08/17/1992
Decision Substantially Equivalent - Kit (SESK)
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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