The following data is part of a premarket notification filed by Scholten Surgical Instruments, Inc. with the FDA for Temporary Pacemaker Ground Wire.
| Device ID | K852119 |
| 510k Number | K852119 |
| Device Name: | TEMPORARY PACEMAKER GROUND WIRE |
| Classification | Permanent Pacemaker Electrode |
| Applicant | SCHOLTEN SURGICAL INSTRUMENTS, INC. 707 WARRINGTON AVE. Redwood City, CA 94063 |
| Contact | Jake(jacobus) Scholt |
| Correspondent | Jake(jacobus) Scholt SCHOLTEN SURGICAL INSTRUMENTS, INC. 707 WARRINGTON AVE. Redwood City, CA 94063 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-15 |
| Decision Date | 1985-09-15 |