510(k) K954470
K954470 is an FDA 510(k) premarket notification submitted by W.O.M. World of Medicine GmbH for the device "SURGIMOTOR". The FDA issued a decision of Substantially Equivalent on December 8, 1995. The device falls under product code GEY (Motor, Surgical Instrument, Ac-Powered), a Class I device regulated under 21 CFR 878.4820. W.O.M. World of Medicine GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 8, 1995
- Date Received
- September 26, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Motor, Surgical Instrument, Ac-Powered
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- SU
- Submission Type