510(k) K833361
K833361 is an FDA 510(k) premarket notification submitted by Sontek Industries, Inc. for the device "TUBE-TITLE". The FDA issued a decision of Substantially Equivalent on November 3, 1983. The device falls under product code JAY (Support, Breathing Tube), a Class I device regulated under 21 CFR 868.5280. Sontek Industries, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 3, 1983
- Date Received
- September 27, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Support, Breathing Tube
- Device Class
- Class I
- Regulation Number
- 868.5280
- Review Panel
- AN
- Submission Type