510(k) K864181
K864181 is an FDA 510(k) premarket notification submitted by Somatics, Inc. for the device "SOMATICS MOUTH GUARD (BITE BLOCK)". The FDA issued a decision of Substantially Equivalent on November 3, 1986. The device falls under product code JXL (Block, Bite), a Class II device regulated under 21 CFR 882.5070. Somatics, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 3, 1986
- Date Received
- October 27, 1986
- 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