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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(k) Number K041545
Device Name CONTACT DETACH
Applicant
UNOMEDICAL A/S
AAHOLMVEJ 1-3, OSTED
ROSKILDE,  DK DK-4000
Applicant Contact JOHN M LINDSKOG
Correspondent
UNOMEDICAL A/S
AAHOLMVEJ 1-3, OSTED
ROSKILDE,  DK DK-4000
Correspondent Contact JOHN M LINDSKOG
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/09/2004
Decision Date 06/30/2004
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
Recalls CDRH Recalls
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