Device Classification Name |
transilluminator, ac-powered
|
510(k) Number |
K894513 |
Device Name |
DIATHRON(R) DIATHERMY UNIT |
Applicant |
INTL. OPHTHALMIC INDUSTRIES CORP. |
54 BAY STATE RD. |
WESTON,
MA
02193
|
|
Applicant Contact |
HILLARD W WELCH |
Correspondent |
INTL. OPHTHALMIC INDUSTRIES CORP. |
54 BAY STATE RD. |
WESTON,
MA
02193
|
|
Correspondent Contact |
HILLARD W WELCH |
Regulation Number | 886.1945
|
Classification Product Code |
|
Date Received | 07/19/1989 |
Decision Date | 10/31/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|