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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 K971664
Device Name RAMY PISTON SYRINGE
Applicant
Alshifa Medical Syringes Mfg. Co., Ltd.
55 Northern Blvd., Suite 410
Great Neck,,  NY  11021
Applicant Contact MILTON N BENEKE
Correspondent
Alshifa Medical Syringes Mfg. Co., Ltd.
55 Northern Blvd., Suite 410
Great Neck,,  NY  11021
Correspondent Contact MILTON N BENEKE
Regulation Number880.5860
Classification Product Code
FMF  
Date Received05/06/1997
Decision Date 07/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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