WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS


Device Classification Name

pump, infusion

510(k) Number K991275
Device Name WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS
Applicant
MCKINLEY, INC.
4080 youngfield st.
wheat ridge, 
CO 
80033

Applicant Contact john mcinroy
Correspondent
MCKINLEY, INC.
4080 youngfield st.
wheat ridge, 
CO 
80033

Correspodent Contact john mcinroy
Regulation Number 880.5725
Classification Product Code
FRN  
Date Received 04/14/1999
Decision Date 07/01/1999
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

Category: Uncategorized