The following data is part of a premarket notification filed by Intl. Ophthalmic Industries Corp. with the FDA for Diathron(r) Diathermy Unit.
| Device ID | K894513 |
| 510k Number | K894513 |
| Device Name: | DIATHRON(R) DIATHERMY UNIT |
| Classification | Transilluminator, Ac-powered |
| Applicant | INTL. OPHTHALMIC INDUSTRIES CORP. 54 BAY STATE RD. Weston, MA 02193 |
| Contact | Hillard W Welch |
| Correspondent | Hillard W Welch INTL. OPHTHALMIC INDUSTRIES CORP. 54 BAY STATE RD. Weston, MA 02193 |
| Product Code | HJM |
| CFR Regulation Number | 886.1945 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-19 |
| Decision Date | 1989-10-31 |