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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name clip, implantable
510(K) Number K100242
Device Name AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER
Applicant
SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE
60 middletown ave.
north haven,  CT  06473
Contact nishith desai
Regulation Number878.4300
Classification Product Code
FZP  
Subsequent Product Code
GDO  
Date Received01/27/2010
Decision Date 02/17/2010
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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