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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 K003406
Device Name GUARDED NEEDLE 2000
Applicant
International Medical Device Partners, Inc.
6801 Iris Cir.
Los Angeles,  CA  90068
Applicant Contact JAMES R GREENWOOD
Correspondent
International Medical Device Partners, Inc.
6801 Iris Cir.
Los Angeles,  CA  90068
Correspondent Contact JAMES R GREENWOOD
Regulation Number880.5570
Classification Product Code
FMI  
Subsequent Product Code
MEG  
Date Received11/01/2000
Decision Date 01/12/2001
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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