510(k) K982128
K982128 is an FDA 510(k) premarket notification submitted by Pilling Weck Surgical for the device "SHIKANI-FRENCH SPEAKING VALVE". The FDA issued a decision of Substantially Equivalent on October 23, 1998. The device falls under product code JOH (Tube Tracheostomy And Tube Cuff), a Class II device regulated under 21 CFR 868.5800. Pilling Weck Surgical has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 23, 1998
- Date Received
- June 17, 1998
- 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