510(k) K842788
K842788 is an FDA 510(k) premarket notification submitted by Brimms, Inc. for the device "DIFFERENTIAL DIAG. OCCLUSAL APPLIANCE". The FDA issued a decision of Substantially Equivalent on September 11, 1984. The device falls under product code JXL (Block, Bite), a Class II device regulated under 21 CFR 882.5070. Brimms, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 1984
- Date Received
- July 23, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Block, Bite
- Device Class
- Class II
- Regulation Number
- 882.5070
- Review Panel
- NE
- Submission Type