510(k) K871315
K871315 is an FDA 510(k) premarket notification submitted by Endovations for the device "ORAL ASPIRATOR". The FDA issued a decision of Substantially Equivalent on Apr 15, 1987. The device falls under product code DYN (Mouthpiece, Saliva Ejector), a Class I device regulated under 21 CFR 872.6640. Endovations has 37 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 15, 1987
- Date Received
- Apr 1, 1987
- 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