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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 K071796
Device Name CAPSEW PLICATION SYSTEM
Applicant
CAYENNE MEDICAL, INC.
11234 EL CAMINO REAL
SUITE 200
SAN DIEGO,  CA  92130
Applicant Contact DAVID J COLLETTE
Correspondent
CAYENNE MEDICAL, INC.
11234 EL CAMINO REAL
SUITE 200
SAN DIEGO,  CA  92130
Correspondent Contact DAVID J COLLETTE
Regulation Number878.5000
Classification Product Code
GAT  
Date Received07/02/2007
Decision Date 10/19/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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