510(k) K934117
K934117 is an FDA 510(k) premarket notification submitted by Garrett Medical Products for the device "STABILTUBE". The FDA issued a decision of Substantially Equivalent on October 25, 1993. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Garrett Medical Products has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 25, 1993
- Date Received
- August 24, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Tracheal (W/Wo Connector)
- Device Class
- Class II
- Regulation Number
- 868.5730
- Review Panel
- AN
- Submission Type