AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS


Device Classification Name

catheter, hemodialysis, non-implanted

510(k) Number K110793
Device Name AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS
Applicant
AMECO MEDICAL INDUSTRIES
79 brookline road
mason, 
NH 
03048

Applicant Contact ray kelly
Correspondent
AMECO MEDICAL INDUSTRIES
79 brookline road
mason, 
NH 
03048

Correspodent Contact ray kelly
Regulation Number 876.5540
Classification Product Code
MPB  
Date Received 03/22/2011
Decision Date 12/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No