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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 K121413
Models CM-8001, CM-8002
Device Name CROSSFIX II MEMISCAL REPAIR DEVICE
Original Applicant
CAYENNE MEDICAL, INC.
16597 n. 92nd street
suite 101
scottsdale,  AZ  85260
Original Contact kereshmeh shahriari
Regulation Number878.5000
Classification Product Code
GAT  
Date Received05/11/2012
Decision Date 06/04/2012
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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