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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K982966
Device Name DISETRONIC PEN
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 Number880.5860
Classification Product Code
FMF  
Date Received08/25/1998
Decision Date 10/19/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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