AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS


Device Classification Name

catheter,intravascular,therapeutic,short-term less than 30 days

510(k) Number K110794
Device Name AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION 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 880.5200
Classification Product Code
FOZ  
Date Received 03/22/2011
Decision Date 12/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No