The following data is part of a premarket notification filed by Scholten Surgical Instruments, Inc. with the FDA for Stand, Operating Room.
| Device ID | K852329 |
| 510k Number | K852329 |
| Device Name: | STAND, OPERATING ROOM |
| Classification | Stand, Infusion |
| Applicant | SCHOLTEN SURGICAL INSTRUMENTS, INC. 707 WARRINGTON AVE. Redwood City, CA 94063 |
| Contact | Jacobus Scholten |
| Correspondent | Jacobus Scholten SCHOLTEN SURGICAL INSTRUMENTS, INC. 707 WARRINGTON AVE. Redwood City, CA 94063 |
| Product Code | FOX |
| CFR Regulation Number | 880.6990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-31 |
| Decision Date | 1985-06-14 |