510(k) K884473
K884473 is an FDA 510(k) premarket notification submitted by Neo Contemporary Co. for the device "RUBIN BONE PLANER W/REPLACEABLE BLADE". The FDA issued a decision of Substantially Equivalent on December 9, 1988. The device falls under product code GAC (Rasp, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 1988
- Date Received
- October 25, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rasp, Surgical, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type