The following data is part of a premarket notification filed by O.r. Specialties, Inc. with the FDA for J105 James Surgical System I/a Pack.
| Device ID | K911932 |
| 510k Number | K911932 |
| Device Name: | J105 JAMES SURGICAL SYSTEM I/A PACK |
| Classification | Instrument, Microsurgical |
| 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 | GZX |
| CFR Regulation Number | 882.4525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-30 |
| Decision Date | 1991-08-26 |