510(k) K960473
K960473 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "AESCULAP POWER SYSTEM HANDPIECE". The FDA issued a decision of Substantially Equivalent on March 7, 1996. The device falls under product code GET (Motor, Surgical Instrument, Pneumatic Powered), a Class I device regulated under 21 CFR 878.4820. Aesculap, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 7, 1996
- Date Received
- February 1, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Motor, Surgical Instrument, Pneumatic Powered
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- SU
- Submission Type