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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 K073493
Device Name HEPATOSTAT SET
Applicant
VYGON CORP.
2495 GENERAL ARMISTEAD AVE
NORRISTOWN,  PA  19403
Applicant Contact COURTNEY SMITH
Correspondent
VYGON CORP.
2495 GENERAL ARMISTEAD AVE
NORRISTOWN,  PA  19403
Correspondent Contact COURTNEY SMITH
Regulation Number878.4493
Classification Product Code
GAM  
Subsequent Product Code
GDJ  
Date Received12/12/2007
Decision Date 05/06/2008
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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