GELPOINT PATH


Device Classification Name

anoscope and accessories

510(k) Number K110792
Device Name GELPOINT PATH
Applicant
APPLIED MEDICAL RESOURCES CORP.
22872 avenida empresa
rancho santa margarita, 
CA 
92688

Applicant Contact frans vandenbroek
Regulation Number 876.1500
Classification Product Code
FER  
Date Received 03/21/2011
Decision Date 05/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No