The following data is part of a premarket notification filed by A.r.c. Laser Ag with the FDA for Laser Pack I, Laser Pack Ii, Phaco Pack I, Phaco Pack Ii.
| Device ID | K003512 |
| 510k Number | K003512 |
| Device Name: | LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II |
| Classification | Unit, Phacofragmentation |
| Applicant | A.R.C. LASER AG 2417 SOUTH 3850 WEST Salt Lake City, UT 84120 |
| Contact | Daniel Hoefer |
| Correspondent | Daniel Hoefer A.R.C. LASER AG 2417 SOUTH 3850 WEST Salt Lake City, UT 84120 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-14 |
| Decision Date | 2001-02-08 |