510(k) K863768
K863768 is an FDA 510(k) premarket notification submitted by The Medical Group, Inc. for the device "SALIVA EJECTORS". The FDA issued a decision of Substantially Equivalent on Oct 27, 1986. The device falls under product code DYN (Mouthpiece, Saliva Ejector), a Class I device regulated under 21 CFR 872.6640. The Medical Group, Inc. has 15 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 27, 1986
- Date Received
- Sep 25, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mouthpiece, Saliva Ejector
- Device Class
- Class I
- Regulation Number
- 872.6640
- Review Panel
- DE
- Submission Type
- 510(k) Exempt