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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 K883073
Device Name N.M.D.C. USER PROTECTIVE HYPODERMIC SYRINGE SYSTEM
Applicant
National Medical Device Corp.
99 W. Hawthorne Ave.
Valley Stream,  NY  11580
Applicant Contact TOMKIEL, BS
Correspondent
National Medical Device Corp.
99 W. Hawthorne Ave.
Valley Stream,  NY  11580
Correspondent Contact TOMKIEL, BS
Regulation Number880.5860
Classification Product Code
FMF  
Date Received07/20/1988
Decision Date 02/28/1989
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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