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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 K061276
Device Name G-PROX ENDOSCOPIC GRASPER
Applicant
USGI MEDICAL
1140 CALLE CORDILLERA
SAN CLEMENTE,  CA  92673
Applicant Contact MARY LOU MOONEY
Correspondent
USGI MEDICAL
1140 CALLE CORDILLERA
SAN CLEMENTE,  CA  92673
Correspondent Contact MARY LOU MOONEY
Regulation Number878.5000
Classification Product Code
GAT  
Subsequent Product Codes
GDW   HET  
Date Received05/08/2006
Decision Date 12/06/2006
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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