Device Classification Name |
pack, hot or cold, water circulating
|
510(k) Number |
K843146 |
FOIA Releasable 510(k) |
K843146
|
Device Name |
MICRO-TEMP PUMPS & MICRO-TEMP PADS |
Applicant |
SEABROOK MEDICAL SYSTEMS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
SEABROOK MEDICAL SYSTEMS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 890.5720
|
Classification Product Code |
|
Date Received | 08/10/1984 |
Decision Date | 08/17/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|