510(k) K854765
K854765 is an FDA 510(k) premarket notification submitted by C&C Systems, Inc. for the device "INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH". The FDA issued a decision of Substantially Equivalent on June 13, 1986. The device falls under product code EHP (Clasp, Preformed), a Class I device regulated under 21 CFR 872.3285.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 1986
- Date Received
- November 27, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clasp, Preformed
- Device Class
- Class I
- Regulation Number
- 872.3285
- Review Panel
- DE
- Submission Type