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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Surgical Instrument, Disposable
510(k) Number K920516
Device Name GENERAL PURPOSE INSTRUMENT TRAY, STERILE, DISPOSAB
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 Number878.4800
Classification Product Code
KDD  
Date Received02/04/1992
Decision Date 04/16/1992
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General & Plastic Surgery
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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