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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 K010887
Device Name INSULIN PEN NEEDLE ADAPTER
Applicant
Ohana Needle Co.
64 Cheever Cir.
Andover,  MA  01810
Applicant Contact SPENCER H OWADES
Correspondent
Ohana Needle Co.
64 Cheever Cir.
Andover,  MA  01810
Correspondent Contact SPENCER H OWADES
Regulation Number880.5570
Classification Product Code
FMI  
Date Received03/26/2001
Decision Date 06/08/2001
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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