510(k) K936133
K936133 is an FDA 510(k) premarket notification submitted by Smiths Industries Medical Systems, Inc. for the device "PERCUTANEOUS TRACHEOSTOMY KIT". The FDA issued a decision of Substantially Equivalent (kit, denovo) on March 23, 1994. The device falls under product code JOH (Tube Tracheostomy And Tube Cuff), a Class II device regulated under 21 CFR 868.5800. Smiths Industries Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SEKD (Substantially Equivalent (kit, denovo))
- Decision Date
- March 23, 1994
- Date Received
- December 23, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube Tracheostomy And Tube Cuff
- Device Class
- Class II
- Regulation Number
- 868.5800
- Review Panel
- AN
- Submission Type