510(k) K823320
K823320 is an FDA 510(k) premarket notification submitted by Miltex, Inc. for the device "DENTAL INSTRUMENTS - BONE CHISELS". The FDA issued a decision of Substantially Equivalent on Nov 24, 1982. The device falls under product code EML (Chisel, Bone, Surgical), a Class I device regulated under 21 CFR 872.4565. Miltex, Inc. has 22 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 24, 1982
- Date Received
- Nov 8, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Chisel, Bone, Surgical
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type
- 510(k) Exempt