The following data is part of a premarket notification filed by O.r. Specialties, Inc. with the FDA for Phaco Needles 1000-r & 1000-o Needles.
| Device ID | K923630 |
| 510k Number | K923630 |
| Device Name: | PHACO NEEDLES 1000-R & 1000-O NEEDLES |
| Classification | Unit, Phacofragmentation |
| Applicant | O.R. SPECIALTIES, INC. 4749 APPLETREE LN. Tuscaloosa, AL 35405 |
| Contact | Jack W Howard |
| Correspondent | Jack W Howard O.R. SPECIALTIES, INC. 4749 APPLETREE LN. Tuscaloosa, AL 35405 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-21 |
| Decision Date | 1994-04-06 |