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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid
510(k) Number K061796
Device Name HEPATOSTAT SET, MODEL 760X
Applicant
Vygon Corp.
30833 Northwesters Hwy
Suite 121
Farmington Hills,  MI  48334
Applicant Contact STEPHEN GOLDNER
Correspondent
Vygon Corp.
30833 Northwesters Hwy
Suite 121
Farmington Hills,  MI  48334
Correspondent Contact STEPHEN GOLDNER
Regulation Number878.4493
Classification Product Code
GAM  
Subsequent Product Code
GDJ  
Date Received06/26/2006
Decision Date 11/02/2006
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
Predetermined Change
Control Plan Authorized		 No
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