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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name i.v. start kit
510(k) Number K923361
Device Name I.V. START KIT, 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 Number880.5200
Classification Product Code
LRS  
Date Received07/08/1992
Decision Date 06/28/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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