The following data is part of a premarket notification filed by Scholten Surgical Instruments, Inc. with the FDA for Sys, Angiographic, Single-or Bi-plane Radiographic.
| Device ID | K852331 |
| 510k Number | K852331 |
| Device Name: | SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC |
| Classification | System, X-ray, Angiographic |
| 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 | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-31 |
| Decision Date | 1986-08-01 |