PREFILLED CATHETER INFLATION SYRINGE


Device Classification Name

accessories, catheter, g-u

510(k) Number K112209
Device Name PREFILLED CATHETER INFLATION SYRINGE
Applicant
AVAIL MEDICAL PRODUCTS, INC.
5950 nancy ridge road
suite 500
san diego, 
CA 
92121

Applicant Contact steven a howell
Correspondent
AVAIL MEDICAL PRODUCTS, INC.
5950 nancy ridge road
suite 500
san diego, 
CA 
92121

Correspodent Contact steven a howell
Regulation Number 876.5130
Classification Product Code
KNY  
Date Received 08/01/2011
Decision Date 09/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No