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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
Device Name CROSSFIX II MEMISCAL REPAIR DEVICE
Applicant
CAYENNE MEDICAL, INC.
16597 N. 92ND STREET
SUITE 101
SCOTTSDALE,  AZ  85260
Applicant Contact KERESHMEH SHAHRIARI
Correspondent
CAYENNE MEDICAL, INC.
16597 N. 92ND STREET
SUITE 101
SCOTTSDALE,  AZ  85260
Correspondent Contact KERESHMEH SHAHRIARI
Regulation Number878.5000
Classification Product Code
GAT  
Date Received05/11/2012
Decision Date 06/04/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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