HEPATOSTAT SET


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

Correspodent Contact courtney smith
Regulation Number 878.4493
Classification Product Code
GAM  
Subsequent Product Code
GDJ  
Date Received 12/12/2007
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