The following data is part of a premarket notification filed by Medical Instrument Development Laboratories, Inc. with the FDA for Infusion Sleeve - Ophthalmic.
| Device ID | K851009 |
| 510k Number | K851009 |
| Device Name: | INFUSION SLEEVE - OPHTHALMIC |
| Classification | Unit, Phacofragmentation |
| Applicant | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. 2235 POLVOROSA AVE. SUITE 200 San Leandro, CA 94577 |
| Contact | William T George |
| Correspondent | William T George MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. 2235 POLVOROSA AVE. SUITE 200 San Leandro, CA 94577 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-12 |
| Decision Date | 1985-04-03 |