The following data is part of a premarket notification filed by Syntec Scientific Corp. with the FDA for Non-sterile Kirschner Wires And Steinmann Pins, Models #'s 290-101/160, 290-201/216, 290-060/330, 290-161/220.
| Device ID | K983121 |
| 510k Number | K983121 |
| Device Name: | NON-STERILE KIRSCHNER WIRES AND STEINMANN PINS, MODELS #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220 |
| Classification | Pin, Fixation, Smooth |
| Applicant | SYNTEC SCIENTIFIC CORP. 2, KUNG SAN ROAD, CHAUN SHING INDUSTRIAL ZONE, SHEN KANG Chang Hua, TW 509 |
| Contact | Ted Y Shi |
| Correspondent | Ted Y Shi SYNTEC SCIENTIFIC CORP. 2, KUNG SAN ROAD, CHAUN SHING INDUSTRIAL ZONE, SHEN KANG Chang Hua, TW 509 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-08 |
| Decision Date | 1998-10-05 |
| Summary: | summary |