510(k) K050518
- Device
- REPROCESSED PHACOEMUISIFICATION TIPS
- Applicant
- ALLIANCE MEDICAL, INC.
- 510(k) number
- K050518
- Product code
- NKX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-09-23
- Date received
- 2005-03-01
- Regulation
- 886.4670
- Classification name
- Needle, Phacoemulsification, Reprocessed
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ELIZABETH RENKEN
- Address
- 10232 S. 51 St. Phoenix AZ US 85044 85044
FDA Registration Numbers#
- 1054713
- 3032391
Source Documents#
Other 510(k) Records For Product Code NKX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K060648 | REPROCESSED PHACOEMULSIFICATION TIPS | Alliance Medical Corp. | 2007-03-19 |
| K030179 | MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES | Surgical Instruments Service and Savings, Inc. | 2003-01-24 |
| K012698 | VANGUARD REPROCESSED PHACOEMULSIFICATION | Vanguard Medical Concepts, Inc. | 2001-11-09 |
| K012579 | REPROCESSED PHACO TIPS | Sterilmed, Inc. | 2001-11-08 |
Legacy Summary#
summary
FDA Review#
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