The following data is part of a premarket notification filed by Ortho-j, Inc. with the FDA for Ortho-j, Inc. Bek-js-004.
| Device ID | K891917 |
| 510k Number | K891917 |
| Device Name: | ORTHO-J, INC. BEK-JS-004 |
| Classification | Table, Surgical With Orthopedic Accessories, Manual |
| Applicant | ORTHO-J, INC. ATTORNEY AT LAW 1206 NORTH RIDGE AVENUE Tifton, GA 31793 |
| Contact | Hugh Gordon |
| Correspondent | Hugh Gordon ORTHO-J, INC. ATTORNEY AT LAW 1206 NORTH RIDGE AVENUE Tifton, GA 31793 |
| Product Code | JEB |
| CFR Regulation Number | 878.4950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-27 |
| Decision Date | 1989-05-26 |