510(k) K810059
K810059 is an FDA 510(k) premarket notification submitted by Ackrad Laboratories for the device "ENDO-MED TUBE FOR ENDOTRACHEAL MED". The FDA issued a decision of Substantially Equivalent on February 26, 1981. The device falls under product code CCT (Applicator (Laryngo-Tracheal), Topical Anesthesia), a Class II device regulated under 21 CFR 868.5170. Ackrad Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 26, 1981
- Date Received
- January 13, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Applicator (Laryngo-Tracheal), Topical Anesthesia
- Device Class
- Class II
- Regulation Number
- 868.5170
- Review Panel
- AN
- Submission Type