T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP


Device Classification Name

pack, hot or cold, water circulating

510(k) Number K073675
Device Name T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP
Applicant
GAYMAR INDUSTRIES, INC.
140 pearl street, suite 100
buffalo, 
NY 
14202

Applicant Contact bethany j gilbert
Correspondent
GAYMAR INDUSTRIES, INC.
140 pearl street, suite 100
buffalo, 
NY 
14202

Correspodent Contact bethany j gilbert
Regulation Number 890.5720
Classification Product Code
ILO  
Date Received 12/28/2007
Decision Date 05/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No