510(k) K991625
K991625 is an FDA 510(k) premarket notification submitted by Komet Medical for the device "KOMET XK-95 PERFORATOR MOTOR (MI-102)". The FDA issued a decision of Substantially Equivalent on July 30, 1999. The device falls under product code HBB (Motor, Drill, Pneumatic), a Class II device regulated under 21 CFR 882.4370. Komet Medical has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 1999
- Date Received
- May 11, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Motor, Drill, Pneumatic
- Device Class
- Class II
- Regulation Number
- 882.4370
- Review Panel
- NE
- Submission Type