The following data is part of a premarket notification filed by Scholten Surgical Instruments, Inc. with the FDA for Scholten Frame.
| Device ID | K900405 |
| 510k Number | K900405 |
| Device Name: | SCHOLTEN FRAME |
| Classification | Table, Surgical With Orthopedic Accessories, Manual |
| Applicant | SCHOLTEN SURGICAL INSTRUMENTS, INC. 100 HEGENBERGER RD. SUITE 210 Oakland, CA 94621 |
| Contact | J Donaldson |
| Correspondent | J Donaldson SCHOLTEN SURGICAL INSTRUMENTS, INC. 100 HEGENBERGER RD. SUITE 210 Oakland, CA 94621 |
| Product Code | JEB |
| CFR Regulation Number | 878.4950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-29 |
| Decision Date | 1990-03-01 |