ULTIMED ULTICARE SAFETY SYRINGE


Device Classification Name

syringe, antistick

510(k) Number K080600
Device Name ULTIMED ULTICARE SAFETY SYRINGE
Applicant
ULTIMED, INC.
5353 wayzata blvd.
suite 505
minneapolis, 
MN 
55416 -1334

Applicant Contact carole stamp
Correspondent
ULTIMED, INC.
5353 wayzata blvd.
suite 505
minneapolis, 
MN 
55416 -1334

Correspodent Contact carole stamp
Regulation Number 880.5860
Classification Product Code
MEG  
Date Received 03/03/2008
Decision Date 06/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No