Device Classification Name |
Pack, Hot Or Cold, Water Circulating
|
510(k) Number |
K920581 |
Device Name |
POLAR PAD (STERILE) |
Applicant |
BREG, INC. |
344 22ND ST. |
COSTA MESA,
CA
92627
|
|
Applicant Contact |
NANCY A WILLCOX |
Correspondent |
BREG, INC. |
344 22ND ST. |
COSTA MESA,
CA
92627
|
|
Correspondent Contact |
NANCY A WILLCOX |
Regulation Number | 890.5720
|
Classification Product Code |
|
Date Received | 02/10/1992 |
Decision Date | 03/20/1992 |
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
|
|
|