510(k) K770600
K770600 is an FDA 510(k) premarket notification submitted by W.H. Wall, D.D.S. for the device "OROPHARYNGEAL SUCTION AIRWAY". The FDA issued a decision of Substantially Equivalent on April 8, 1977. The device falls under product code EBR (Unit, Suction Operatory), a Class I device regulated under 21 CFR 872.6640.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 1977
- Date Received
- March 29, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Suction Operatory
- Device Class
- Class I
- Regulation Number
- 872.6640
- Review Panel
- DE
- Submission Type