Device Classification Name |
Pack, Hot Or Cold, Disposable
|
510(k) Number |
K936084 |
Device Name |
OMNI WARM GEL PACKS |
Applicant |
OMNI THERM, INC. |
2338 WELDON PKWY. |
ST. LOUIS,
MO
63146
|
|
Applicant Contact |
DALE E WALTERS |
Correspondent |
OMNI THERM, INC. |
2338 WELDON PKWY. |
ST. LOUIS,
MO
63146
|
|
Correspondent Contact |
DALE E WALTERS |
Regulation Number | 890.5710
|
Classification Product Code |
|
Date Received | 12/21/1993 |
Decision Date | 03/31/1994 |
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
|
|
|