510(k) K030179
- Device
- MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES
- Applicant
- SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC.
- 510(k) number
- K030179
- Product code
- NKX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-01-24
- Date received
- 2003-01-17
- Regulation
- 886.4670
- Classification name
- Needle, Phacoemulsification, Reprocessed
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- MARY ANN BARKER
- Address
- 723 Curtis Ct; P.O. Box 2060 Sisters OR US 97759 97759
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 |
| 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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