510(k) K810960
K810960 is an FDA 510(k) premarket notification submitted by Vesta, Inc. for the device "NASOPHARYNGEAL AIRWAY". The FDA issued a decision of Substantially Equivalent on April 23, 1981. The device falls under product code BTQ (Airway, Nasopharyngeal), a Class I device regulated under 21 CFR 868.5100. Vesta, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 1981
- Date Received
- April 8, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Airway, Nasopharyngeal
- Device Class
- Class I
- Regulation Number
- 868.5100
- Review Panel
- AN
- Submission Type