510(k) K983757
K983757 is an FDA 510(k) premarket notification submitted by Syntec Scientific Corp. for the device "SYNTEC-TAICHUNG NON-STERILE KNOWLES PIN, MODELS: FOR HEXAGONAL COLLAR: 2991-01/15,2992-01/15, FOR SQUARE COLLAR:29992-01". The FDA issued a decision of Substantially Equivalent on Dec 4, 1998. The device falls under product code JDW (Pin, Fixation, Threaded), a Class II device regulated under 21 CFR 888.3040. Syntec Scientific Corp. has 12 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 4, 1998
- Date Received
- Oct 23, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Pin, Fixation, Threaded
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type
- 510(k)