AXIOM FASCIAL CLOSURE SYSTEM


Device Classification Name

endoscopic tissue approximation device

510(k) Number K103412
Device Name AXIOM FASCIAL CLOSURE SYSTEM
Applicant
AXIOM TECHNOLOGY PARTNERS, LLC
2939 alhambra drive
belmont, 
CA 
94002

Applicant Contact richard rush
Correspondent
AXIOM TECHNOLOGY PARTNERS, LLC
2939 alhambra drive
belmont, 
CA 
94002

Correspodent Contact richard rush
Regulation Number 876.1500
Classification Product Code
OCW  
Subsequent Product Codes
GCJ   HCF  
Date Received 11/22/2010
Decision Date 12/30/2010
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No