The following data is part of a premarket notification filed by Surgical Instruments Service And Savings, Inc. with the FDA for Medisiss Phacoemulsification Tips/needles.
| Device ID | K030179 |
| 510k Number | K030179 |
| Device Name: | MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES |
| Classification | Needle, Phacoemulsification, Reprocessed |
| Applicant | SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC. 723 CURTIS CT; PO BOX 2060 Sisters, OR 97759 |
| Contact | Mary Ann Barker |
| Correspondent | Charles F Mack UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | NKX |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-01-17 |
| Decision Date | 2003-01-24 |
| Summary: | summary |