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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 K982399
Device Name DISETRONIC PENFINE INJECTION PEN NEEDLE
Applicant
DISETRONIC MEDICAL SYSTEMS
7690 CAMERON CIRCLE
FT. MEYERS,  FL  33912
Applicant Contact PATRIK DE HAES
Correspondent
DISETRONIC MEDICAL SYSTEMS
7690 CAMERON CIRCLE
FT. MEYERS,  FL  33912
Correspondent Contact PATRIK DE HAES
Regulation Number880.5570
Classification Product Code
FMI  
Date Received07/10/1998
Decision Date 08/06/1998
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
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