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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 K890473
Device Name NEEDLE GUARD(TM)
Applicant
Martech Medical Products, Inc.
7555 Jurupa Ave.
Suite E
Riverside,  CA  92504
Applicant Contact MICHAEL D MARTELL
Correspondent
Martech Medical Products, Inc.
7555 Jurupa Ave.
Suite E
Riverside,  CA  92504
Correspondent Contact MICHAEL D MARTELL
Regulation Number880.5570
Classification Product Code
FMI  
Date Received01/31/1989
Decision Date 04/03/1989
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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