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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 K082518
Device Name DUAL NEEDLE SUTURE PASSER SYSTEM
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 Received09/02/2008
Decision Date 01/16/2009
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
Predetermined Change
Control Plan Authorized		 No
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