The following data is part of a premarket notification filed by Medical Technical Products with the FDA for Model 2000 Ophthalmic Surgical System.
| Device ID | K940084 |
| 510k Number | K940084 |
| Device Name: | MODEL 2000 OPHTHALMIC SURGICAL SYSTEM |
| Classification | Unit, Phacofragmentation |
| Applicant | MEDICAL TECHNICAL PRODUCTS 23042 ALCALDE, SUITE A Laguna Hills, CA 92653 |
| Contact | James H Bakos |
| Correspondent | James H Bakos MEDICAL TECHNICAL PRODUCTS 23042 ALCALDE, SUITE A Laguna Hills, CA 92653 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-07 |
| Decision Date | 1994-06-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850039020384 | K940084 | 000 |
| 00850039020377 | K940084 | 000 |
| 00850039020360 | K940084 | 000 |
| 00850039020353 | K940084 | 000 |
| 00850039020049 | K940084 | 000 |
| 00850039020032 | K940084 | 000 |
| 00850039020025 | K940084 | 000 |
| 00850039020018 | K940084 | 000 |
| 00850039020001 | K940084 | 000 |