REPROCESSED PHACOEMULSIFICATION TIPS
FDA 510(k) clearance K060648 · decided 2007-03-19
Clearance details
- K-number
- K060648
- Device name
- REPROCESSED PHACOEMULSIFICATION TIPS
- Applicant
- Alliance Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-03-13
- Decision date
- 2007-03-19
- Days to decision
- 371 days
- Clearance type
- Traditional
- Product code
- NKX
- Device class
- 2
- Regulation number
- 886.4670
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Phoenix, AZ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| REPROCESSED PHACOEMUISIFICATION TIPS (K050518) | Alliance Medical, Inc. | 2005-09-23 |
| MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES (K030179) | Surgical Instruments Service and Savings, Inc. | 2003-01-24 |
| VANGUARD REPROCESSED PHACOEMULSIFICATION (K012698) | Vanguard Medical Concepts, Inc. | 2001-11-09 |
| REPROCESSED PHACO TIPS (K012579) | Sterilmed, Inc. | 2001-11-08 |
Recalls involving this device
No recalls on record reference this clearance.