510(k) K810651
K810651 is an FDA 510(k) premarket notification submitted by First Industries, Inc. for the device "ORAL AIRWAYS". The FDA issued a decision of Substantially Equivalent on Mar 31, 1981. The device falls under product code CAE (Airway, Oropharyngeal, Anesthesiology), a Class I device regulated under 21 CFR 868.5110. First Industries, Inc. has 5 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 31, 1981
- Date Received
- Mar 10, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Airway, Oropharyngeal, Anesthesiology
- Device Class
- Class I
- Regulation Number
- 868.5110
- Review Panel
- AN
- Submission Type
- 510(k) Exempt