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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K950969
Device Name DISPOSABLE SYRINGE
Applicant
Surgiplast , Ltd.
80/4 G.I.D.C. Vatva
Ahmedabad 382 445,  IN
Applicant Contact ASHIT B SHAH
Correspondent
Surgiplast , Ltd.
80/4 G.I.D.C. Vatva
Ahmedabad 382 445,  IN
Correspondent Contact ASHIT B SHAH
Regulation Number880.5860
Classification Product Code
FMF  
Date Received03/02/1995
Decision Date 11/29/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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