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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 K100251
Device Name G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333
Applicant
Usgi Medical
1140 Calle Cordillera
San Clemente,  CA  92673
Applicant Contact MARY L MOONEY
Correspondent
Usgi Medical
1140 Calle Cordillera
San Clemente,  CA  92673
Correspondent Contact MARY L MOONEY
Regulation Number878.5000
Classification Product Code
GAT  
Date Received01/28/2010
Decision Date 02/17/2010
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
Predetermined Change
Control Plan Authorized		 No
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