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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name suture, nonabsorbable, synthetic, polyethylene
510(k) Number K121306
Models OM-8000, OM-8017, OM-8175, OM-8176, OM-8177
Device Name SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE
Original Applicant
ARTHOCARE CORPORATION
7000 west william cannon drive
building one
austin,  TX  78735
Original Contact cheryl frederick
Regulation Number878.5000
Classification Product Code
GAT  
Subsequent Product Code
NBH  
Date Received05/07/2012
Decision Date 07/12/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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