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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 K910520
Device Name SAFETYSNAP SAFETY SYRINGE
Applicant
U.S. Medical Instruments, Inc.
8950 Villa La Jolla Dr.
Suite 2200
La Jolla,  CA  92037
Applicant Contact MATHEW S MAZUR
Correspondent
U.S. Medical Instruments, Inc.
8950 Villa La Jolla Dr.
Suite 2200
La Jolla,  CA  92037
Correspondent Contact MATHEW S MAZUR
Regulation Number880.5860
Classification Product Code
FMF  
Date Received02/06/1991
Decision Date 04/16/1991
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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