The following data is part of a premarket notification filed by Intl. Ophthalmic Industries Corp. with the FDA for Megatron Ophthalmic Surgical System.
| Device ID | K961658 |
| 510k Number | K961658 |
| Device Name: | MEGATRON OPHTHALMIC SURGICAL SYSTEM |
| Classification | Unit, Phacofragmentation |
| Applicant | INTL. OPHTHALMIC INDUSTRIES CORP. 344 ANNABELLE POINT RD. P.O. BOX 628 Centerville, MA 02632 |
| Contact | Hillard W Welch |
| Correspondent | Hillard W Welch INTL. OPHTHALMIC INDUSTRIES CORP. 344 ANNABELLE POINT RD. P.O. BOX 628 Centerville, MA 02632 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-29 |
| Decision Date | 1996-07-23 |