Device Classification Name |
Pack, Hot Or Cold, Water Circulating
|
510(k) Number |
K902269 |
Device Name |
ELECTRI-COOL(TM) LIQUID-CIRCULAT. THERMAL THERAPY |
Applicant |
SEABROOK MEDICAL SYSTEMS, INC. |
673 WILMER AVE. |
CINCINNATI,
OH
45226 -1859
|
|
Applicant Contact |
MARK J BUCH |
Correspondent |
SEABROOK MEDICAL SYSTEMS, INC. |
673 WILMER AVE. |
CINCINNATI,
OH
45226 -1859
|
|
Correspondent Contact |
MARK J BUCH |
Regulation Number | 890.5720
|
Classification Product Code |
|
Date Received | 05/21/1990 |
Decision Date | 06/21/1990 |
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
|
|
|