REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500


Device Classification Name

endoscope and/or accessories

510(k) Number K030170
Device Name REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500
Original Applicant
OPUS MEDICAL, INC.
27127 calle arroyo, suite 1924
san juan capistrano, 
CA 
92675

Original Contact james w hart
Regulation Number 876.1500
Classification Product Code
KOG  
Date Received 01/17/2003
Decision Date 07/28/2003
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