510(k) K080095
K080095 is an FDA 510(k) premarket notification submitted by Medinvents for the device "CORAMATE/SPIROTOME SYSTEM". The FDA issued a decision of Substantially Equivalent on Apr 11, 2008. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Medinvents has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 11, 2008
- Date Received
- Jan 14, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Instrument, Biopsy
- Device Class
- Class II
- Regulation Number
- 876.1075
- Review Panel
- SU
- Submission Type
- 510(k)