510(k) K012579
- Device
- REPROCESSED PHACO TIPS
- Applicant
- STERILMED, INC.
- 510(k) number
- K012579
- Product code
- NKX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-11-08
- Date received
- 2001-08-09
- 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
- PATRICK FLEISCHHACKER
- Address
- 11400 73rd Ave. N Suite 100 Maple Grove MN US 55369 55369
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 |
| K050518 | REPROCESSED PHACOEMUISIFICATION TIPS | Alliance Medical, Inc. | 2005-09-23 |
| 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 |
Legacy Summary#
summary
FDA Review#
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