510(k) K883388
K883388 is an FDA 510(k) premarket notification submitted by Dale T. Dupuis for the device "DENTREK BRIDGE BARS". The FDA issued a decision of Substantially Equivalent on October 6, 1988. The device falls under product code EHO (Bar, Preformed), a Class I device regulated under 21 CFR 872.3165. Dale T. Dupuis has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 6, 1988
- Date Received
- August 10, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bar, Preformed
- Device Class
- Class I
- Regulation Number
- 872.3165
- Review Panel
- DE
- Submission Type