AMT G-J TUBE


Device Classification Name

tubes, gastrointestinal (and accessories)

510(k) Number K110804
Device Name AMT G-J TUBE
Applicant
APPLIED MEDICAL TECHNOLOGY, INC.
8000 katherine boulevard
brecksville, 
OH 
44141

Applicant Contact joshua d meinke
Correspondent
APPLIED MEDICAL TECHNOLOGY, INC.
8000 katherine boulevard
brecksville, 
OH 
44141

Correspodent Contact joshua d meinke
Regulation Number 876.5980
Classification Product Code
KNT  
Date Received 03/22/2011
Decision Date 10/19/2011
Decision

substantially equivalent – kit

(SESK)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No