510(k) K802598
K802598 is an FDA 510(k) premarket notification submitted by The Anspach Effort, Inc. for the device "CARBIDE CUTTING INSTRUMENT/INTRAARTICU". The FDA issued a decision of Substantially Equivalent on November 19, 1980. The device falls under product code HTT (Burr, Orthopedic), a Class I device regulated under 21 CFR 888.4540. The Anspach Effort, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 19, 1980
- Date Received
- October 21, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Burr, Orthopedic
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type