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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name screw, fixation, bone
510(k) Number K030388
Device Name IMPACT SUTURE ANCHOR. MODEL 433510
Original Applicant
BIONX IMPLANTS, LTD.
hermiankatu 6-8 l
tampere,  FI fin-33720
Original Contact tuija annala
Regulation Number888.3040
Classification Product Code
HWC  
Date Received02/05/2003
Decision Date 04/24/2003
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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