Device Classification Name |
lamp, infrared, therapeutic heating
|
510(k) Number |
K081962 |
Device Name |
LAPEX BCS |
Applicant |
MERIDIAN CO., LTD. |
PO BOX 7007 |
DEERFIELD,
IL
60015
|
|
Applicant Contact |
DANIEL KAMM |
Correspondent |
MERIDIAN CO., LTD. |
PO BOX 7007 |
DEERFIELD,
IL
60015
|
|
Correspondent Contact |
DANIEL KAMM |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 07/09/2008 |
Decision Date | 12/29/2008 |
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
|
|
|