510(k) K823676
K823676 is an FDA 510(k) premarket notification submitted by Today'S Machining & Design, Inc. for the device "DISC NEEDLE SET #TX-8220". The FDA issued a decision of Substantially Equivalent on January 9, 1983. The device falls under product code EMI (File, Bone, Surgical), a Class I device regulated under 21 CFR 872.4565. Today'S Machining & Design, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 1983
- Date Received
- December 7, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- File, Bone, Surgical
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type