The following data is part of a premarket notification filed by O.r. Specialties, Inc. with the FDA for James Surgical System J1000.
| Device ID | K890195 |
| 510k Number | K890195 |
| Device Name: | JAMES SURGICAL SYSTEM J1000 |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| 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 | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-18 |
| Decision Date | 1989-08-03 |