510(k) K896321
K896321 is an FDA 510(k) premarket notification submitted by Superior Healthcare Group, Inc. for the device "NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH.". The FDA issued a decision of Substantially Equivalent on November 13, 1989. The device falls under product code BSY (Catheters, Suction, Tracheobronchial), a Class I device regulated under 21 CFR 868.6810. Superior Healthcare Group, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 13, 1989
- Date Received
- November 1, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheters, Suction, Tracheobronchial
- Device Class
- Class I
- Regulation Number
- 868.6810
- Review Panel
- AN
- Submission Type