510(k) K053526
K053526 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "MICROSPEED UNI MOTOR SYSTEM". The FDA issued a decision of Substantially Equivalent on January 18, 2006. The device falls under product code HBC (Motor, Drill, Electric), a Class II device regulated under 21 CFR 882.4360. Aesculap, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 18, 2006
- Date Received
- December 19, 2005
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Motor, Drill, Electric
- Device Class
- Class II
- Regulation Number
- 882.4360
- Review Panel
- NE
- Submission Type