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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Antistick
510(k) Number K925039
Device Name SAFESNAP SAFETY SYRINGE
Applicant
U.S. Medical Instruments, Inc.
3500 Estudillo
San Diego,  CA  92110
Applicant Contact JAMES M ARGANDA
Correspondent
U.S. Medical Instruments, Inc.
3500 Estudillo
San Diego,  CA  92110
Correspondent Contact JAMES M ARGANDA
Regulation Number880.5860
Classification Product Code
MEG  
Date Received10/05/1992
Decision Date 02/16/1994
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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