510(k) K790078
K790078 is an FDA 510(k) premarket notification submitted by Eurodent, Inc. for the device "BAR & RIDER, SCREWS, TUBES". The FDA issued a decision of Substantially Equivalent on February 27, 1979. The device falls under product code ECG (Sterilizer, Boiling Water), a Class I device regulated under 21 CFR 872.6710. Eurodent, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 27, 1979
- Date Received
- January 10, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilizer, Boiling Water
- Device Class
- Class I
- Regulation Number
- 872.6710
- Review Panel
- DE
- Submission Type