510(k) K971002
K971002 is an FDA 510(k) premarket notification submitted by Lloyd V. Ziemendorf for the device "SMILE WITH CONFIDENCE". The FDA issued a decision of Substantially Equivalent on July 15, 1997. The device falls under product code EHS (Cushion, Denture, Over The Counter), a Class II device regulated under 21 CFR 872.3540.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 15, 1997
- Date Received
- March 19, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cushion, Denture, Over The Counter
- Device Class
- Class II
- Regulation Number
- 872.3540
- Review Panel
- DE
- Submission Type