The following data is part of a premarket notification filed by Medical Instrument Development Laboratories with the FDA for Bi-blade Vitrectomy Cutter.
| Device ID | K153168 |
| 510k Number | K153168 |
| Device Name: | Bi-Blade Vitrectomy Cutter |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES 557 MCCORMICK STREET San Leandro, CA 94577 |
| Contact | Brenda Balletto |
| Correspondent | Brenda Balletto MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES 557 MCCORMICK STREET San Leandro, CA 94577 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-02 |
| Decision Date | 2016-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10812480011196 | K153168 | 000 |
| 00812480010826 | K153168 | 000 |
| 00812480010819 | K153168 | 000 |
| 00812480010802 | K153168 | 000 |
| 00812480010796 | K153168 | 000 |
| 00812480010789 | K153168 | 000 |
| 00812480010772 | K153168 | 000 |
| 00812480010765 | K153168 | 000 |
| 00812480010758 | K153168 | 000 |
| 00812480010741 | K153168 | 000 |
| 10812480010731 | K153168 | 000 |
| 10812480010724 | K153168 | 000 |
| 10812480011035 | K153168 | 000 |
| 00812480010833 | K153168 | 000 |
| 00812480010840 | K153168 | 000 |
| 10812480011042 | K153168 | 000 |
| 10812480011028 | K153168 | 000 |
| 10812480011011 | K153168 | 000 |
| 00812480010932 | K153168 | 000 |
| 00812480010925 | K153168 | 000 |
| 00812480010918 | K153168 | 000 |
| 00812480010901 | K153168 | 000 |
| 00812480010895 | K153168 | 000 |
| 00812480010888 | K153168 | 000 |
| 00812480010871 | K153168 | 000 |
| 00812480010864 | K153168 | 000 |
| 00812480010857 | K153168 | 000 |
| 00812480011007 | K153168 | 000 |