510(k) K905011
K905011 is an FDA 510(k) premarket notification submitted by Concord/Portex for the device "ORAL PHARYNGEAL CLEANSING DEVICE". The FDA issued a decision of Substantially Equivalent on January 31, 1991. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640. Concord/Portex has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 1991
- Date Received
- November 7, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Operative Dental
- Device Class
- Class I
- Regulation Number
- 872.6640
- Review Panel
- DE
- Submission Type