The following data is part of a premarket notification filed by Syntec Scientific Corp. with the FDA for Syntec-taichung Non-sterile Knowles Pin, Models: For Hexagonal Collar: 2991-01/15,2992-01/15, For Square Collar:29992-01.
| Device ID | K983757 |
| 510k Number | K983757 |
| Device Name: | SYNTEC-TAICHUNG NON-STERILE KNOWLES PIN, MODELS: FOR HEXAGONAL COLLAR: 2991-01/15,2992-01/15, FOR SQUARE COLLAR:29992-01 |
| Classification | Pin, Fixation, Threaded |
| 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 | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-23 |
| Decision Date | 1998-12-04 |
| Summary: | summary |