FREEZER TEETHER


Device Classification Name

ring, teething, fluid-filled

510(k) Number K002066
Device Name FREEZER TEETHER
Original Applicant
COOL BABY, INC.
17620 cranbrook rd.
edmond, 
OK 
73003

Original Contact dewayne moore
Regulation Number 872.5550
Classification Product Code
KKO  
Date Received 07/07/2000
Decision Date 09/26/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No