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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name clamp, vascular
510(k) Number K982182
Device Name FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION ARCH MODEL 11168, FEMOSTOP II BILATERAL ADAPT0
Applicant
RADI MEDICAL SYSTEMS AB
PALMBLADSGATAN 10
UPPSALA,  SE S-754 50
Applicant Contact MATS GRANLUND
Correspondent
RADI MEDICAL SYSTEMS AB
PALMBLADSGATAN 10
UPPSALA,  SE S-754 50
Correspondent Contact MATS GRANLUND
Regulation Number870.4450
Classification Product Code
DXC  
Date Received06/22/1998
Decision Date 09/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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