510(k) K911080
K911080 is an FDA 510(k) premarket notification submitted by Apdyne Medical Co. for the device "HYGIENA-TRACH". The FDA issued a decision of Substantially Equivalent on May 20, 1991. The device falls under product code JOH (Tube Tracheostomy And Tube Cuff), a Class II device regulated under 21 CFR 868.5800. Apdyne Medical Co. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 1991
- Date Received
- March 11, 1991
- 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