Device Classification Name |
Lamp, Infrared, Therapeutic Heating
|
510(k) Number |
K991503 |
Device Name |
SACRED CRANE TDP LAMP, MODELS CQ-27, CQ-12, CQ-36 |
Applicant |
UNITED PACIFIC CO., LTD. |
219 SOUTH RAYMOND AVE. |
ALHAMBRA,
CA
91801
|
|
Applicant Contact |
DANIEL YE HUA |
Correspondent |
UNITED PACIFIC CO., LTD. |
219 SOUTH RAYMOND AVE. |
ALHAMBRA,
CA
91801
|
|
Correspondent Contact |
DANIEL YE HUA |
Regulation Number | 890.5500 |
Classification Product Code |
|
Date Received | 04/29/1999 |
Decision Date | 07/28/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|