GEBAUER’S INSTANT ICE


Device Classification Name

refrigerant, topical (vapocoolant)

510(k) Number K021726
Device Name GEBAUER’S INSTANT ICE
Original Applicant
GEBAUER CO.
9410 st. catherine ave.
cleveland, 
OH 
44104

Original Contact suzanne b wojcik
Classification Product Code
MLY  
Date Received 05/24/2002
Decision Date 12/12/2002
Decision

substantially equivalent

(SESE)

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls