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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 K994197
Device Name DISENTRONIC PENFINE INJECTION PEN NEEDLE
Applicant
Disetronic Medical Systems
7690 Cameron Circle
Fort Myers,  FL  33912
Applicant Contact Lee Leichter
Correspondent
Disetronic Medical Systems
7690 Cameron Circle
Fort Myers,  FL  33912
Correspondent Contact Lee Leichter
Regulation Number880.5570
Classification Product Code
FMI  
Date Received12/13/1999
Decision Date 12/29/1999
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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