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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 K070253
Device Name AXYA SUTURE WELDING SYSTEM AND KIT
Applicant
AXYA MEDICAL, INC.
100 CUMMINGS CENTER
SUITE 444C
BEVERLY,  MA  01915
Applicant Contact Howard Schrayer
Correspondent
AXYA MEDICAL, INC.
100 CUMMINGS CENTER
SUITE 444C
BEVERLY,  MA  01915
Correspondent Contact Howard Schrayer
Regulation Number878.5000
Classification Product Code
GAT  
Subsequent Product Code
HCF  
Date Received01/26/2007
Decision Date 07/11/2007
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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