510(k) K072706
K072706 is an FDA 510(k) premarket notification submitted by Conmed Linvatec for the device "MICROCHOICE DRILLS AND SAWS, MICROPOWER DRILLS AND SAWS, MICROPOWER ORALMAX HIGH SPEED DRILL". The FDA issued a decision of Substantially Equivalent on Oct 24, 2007. The device falls under product code HRX (Arthroscope), a Class II device regulated under 21 CFR 888.1100. Conmed Linvatec has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 24, 2007
- Date Received
- Sep 24, 2007
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Arthroscope
- Device Class
- Class II
- Regulation Number
- 888.1100
- Review Panel
- OR
- Submission Type
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).