NDO SURGICAL SURGICAL OVERTUBE


the company

Device Classification Name

endoscope and/or accessories

510(k) Number K002018
Device Name NDO SURGICAL SURGICAL OVERTUBE
Original Applicant
SURGICAL, INC.
125 high street, suite 7
mansfield, 
MA 
02048

Original Contact jeff cerier
Regulation Number 876.1500
Classification Product Code
KOG  
Date Received 07/03/2000
Decision Date 08/17/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

Type Traditional
Reviewed by Third Party No

Combination Product

No