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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 K874414
Device Name HYPODERMIC NEEDLES, SINGLE LUMEN
Applicant
Harbor Medical Devices, Inc.
25 Drydock Ave.
Boston,  MA  02210
Applicant Contact JOSHUA TOLKOFF
Correspondent
Harbor Medical Devices, Inc.
25 Drydock Ave.
Boston,  MA  02210
Correspondent Contact JOSHUA TOLKOFF
Regulation Number880.5570
Classification Product Code
FMI  
Date Received10/28/1987
Decision Date 01/14/1988
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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