AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419)


Device Classification Name

tubes, gastrointestinal (and accessories)

510(k) Number K073034
Device Name AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419)
Applicant
APPLIED MEDICAL TECHNOLOGY, INC.
15653 neo pkwy.
cleveland, 
OH 
44128

Applicant Contact brian baker
Correspondent
APPLIED MEDICAL TECHNOLOGY, INC.
15653 neo pkwy.
cleveland, 
OH 
44128

Correspodent Contact brian baker
Regulation Number 876.5980
Classification Product Code
KNT  
Date Received 10/26/2007
Decision Date 03/14/2008
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