The following data is part of a premarket notification filed by O.r. Specialties, Inc. with the FDA for Lewicky O.r.s. Tubing.
| Device ID | K922180 |
| 510k Number | K922180 |
| Device Name: | LEWICKY O.R.S. TUBING |
| Classification | Device, Irrigation, Ocular Surgery |
| 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 | KYG |
| CFR Regulation Number | 886.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-08 |
| Decision Date | 1992-07-02 |