510(k) K090783
K090783 is an FDA 510(k) premarket notification submitted by Tuttnauer U.S.A Co, Ltd. for the device "TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE". The FDA issued a decision of Substantially Equivalent on August 20, 2009. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Tuttnauer U.S.A Co, Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 20, 2009
- Date Received
- March 23, 2009
- 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