510(k) K885305
K885305 is an FDA 510(k) premarket notification submitted by Cobot Medical Corp. for the device "ACETABULAR CUP PUSHER/IMPACTOR". The FDA issued a decision of Substantially Equivalent on February 8, 1989. The device falls under product code HXO (Pusher, Socket), a Class I device regulated under 21 CFR 888.4540.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 1989
- Date Received
- December 27, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pusher, Socket
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type