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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K905305
Device Name SAFE-SITE NEEDLE COVER
Applicant
North American Medical Products, Inc.
6 White Fir Dr.
Loudonville,  NY  12211
Applicant Contact ARTHUR GIANAKOS
Correspondent
North American Medical Products, Inc.
6 White Fir Dr.
Loudonville,  NY  12211
Correspondent Contact ARTHUR GIANAKOS
Regulation Number880.5570
Classification Product Code
FMI  
Date Received11/28/1990
Decision Date 02/12/1991
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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