AARON VAC 2
FDA 510(k) clearance K952558 · decided 1997-03-19
Clearance details
- K-number
- K952558
- Device name
- AARON VAC 2
- Applicant
- Aaron Medical Industries
- Decision
- Substantially Equivalent
- Date received
- 1995-06-02
- Decision date
- 1997-03-19
- Days to decision
- 656 days
- Clearance type
- Traditional
- Product code
- HKP
- Device class
- 2
- Regulation number
- 886.4150
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- St. Petersburg, FL, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| KEATES I/A SYSTEM FRIGITRONICS 4000 (K822599) | Frigitronics of Connecticut, Inc. | 1982-10-06 |
| EMERGENCY POWER PAC (EMPAC) (K813273) | Optical Micro Systems, Inc. | 1981-12-31 |
| X-VEE (K810152) | Temporaty Surgical Systems | 1981-03-17 |
| EYE-VAC (K801231) | Coburn Optical Ind., Inc. | 1980-07-21 |
| OCUTOME MODEL 8000 (K791898) | Cooper Medical Devices Corp. | 1979-10-30 |
| VITREOUS SUCTION/CUTTER (K791000) | Concept, Inc. | 1979-09-04 |
| STAT (K790893) | Varian Assoc., Inc. | 1979-08-28 |
Recalls involving this device
No recalls on record reference this clearance.