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
|
|
Correspondent Contact |
BETHANY J GILBERT |
Regulation Number | 890.5720
|
Classification Product Code |
|
Date Received | 12/28/2007 |
Decision Date | 05/08/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|