510(k) K962175
K962175 is an FDA 510(k) premarket notification submitted by Smiths Industries Medical Systems, Inc. for the device "PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE". The FDA issued a decision of Substantially Equivalent on January 17, 1997. 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
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 1997
- Date Received
- June 5, 1996
- 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