The following data is part of a premarket notification filed by Microworld Medical Instruments, Inc. with the FDA for Colibri Disposable Vitrectomy Cutter.
| Device ID | K033390 |
| 510k Number | K033390 |
| Device Name: | COLIBRI DISPOSABLE VITRECTOMY CUTTER |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | MICROWORLD MEDICAL INSTRUMENTS, INC. 4640 MALAT ST. Oakland, CA 94601 |
| Contact | Semyon Gambarin |
| Correspondent | Heinz-joerg Steneberg TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-10-23 |
| Decision Date | 2003-11-04 |
| Summary: | summary |