510(k) K910789
K910789 is an FDA 510(k) premarket notification submitted by Kavo America for the device "KAVOKLAVE STEAM AUTOCLAVE". The FDA issued a decision of Substantially Equivalent on Aug 26, 1991. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Kavo America has 19 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 26, 1991
- Date Received
- Feb 25, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Sterilizer, Steam
- Device Class
- Class II
- Regulation Number
- 880.6880
- Review Panel
- HO
- Submission Type
- 510(k)