INFUSION ASPIRATION VITRECTOMY SYS
FDA 510(k) clearance K843391 · decided 1984-12-19
Clearance details
- K-number
- K843391
- Device name
- INFUSION ASPIRATION VITRECTOMY SYS
- Applicant
- Medical Instrument Development Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-08-29
- Decision date
- 1984-12-19
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- HQE
- Device class
- 2
- Regulation number
- 886.4150
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- San Leandro, CA, US
- Third-party review
- No
- Expedited review
- No
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| ULTIMATE VIT ENHAMCER (UVE) (K102222) | Medical Instrument Development Laboratories, Inc. | 2011-04-08 |
| COLIBRI DISPOSABLE VITRECTOMY CUTTER (K033390) | Microworld Medical Instruments, Inc. | 2003-11-04 |
| VMATE MODEL VMM1000 (K030948) | Howard Instruments, Inc. | 2003-06-17 |
| VELOCITY ADVANTAGE (K023939) | Visioncare Devices, Inc. | 2003-04-17 |
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| D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM (K010082) | Dutch Ophthalmic USA, Inc. | 2001-03-12 |
Recalls involving this device
No recalls on record reference this clearance.