510(k) K940535
K940535 is an FDA 510(k) premarket notification submitted by The Anspach Effort, Inc. for the device "AUTO LUBE SYSTEM". The FDA issued a decision of Substantially Equivalent on March 21, 1994. The device falls under product code GEY (Motor, Surgical Instrument, Ac-Powered), a Class I device regulated under 21 CFR 878.4820. The Anspach Effort, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 21, 1994
- Date Received
- February 7, 1994
- 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