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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 K092016
Device Name SUPER-FINE PEN NEEDLE
Applicant
Stat Medical Devices, Inc.
2056 NE 153rd St.
North Miami Beach,  FL  33162
Applicant Contact MARY L JEAN
Correspondent
Stat Medical Devices, Inc.
2056 NE 153rd St.
North Miami Beach,  FL  33162
Correspondent Contact MARY L JEAN
Regulation Number880.5570
Classification Product Code
FMI  
Date Received07/06/2009
Decision Date 10/02/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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