510(k) K962282
K962282 is an FDA 510(k) premarket notification submitted by Tuttnauer U.S.A Co, Ltd. for the device "TUTTNAUER PREVACUUM TABLE AUTOCLAVE". The FDA issued a decision of Substantially Equivalent on November 12, 1997. 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
- November 12, 1997
- Date Received
- June 12, 1996
- 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