510(k) K811241
K811241 is an FDA 510(k) premarket notification submitted by Sontek Industries, Inc. for the device "BODAI SUCTION -SAFE 4". The FDA issued a decision of Substantially Equivalent on May 27, 1981. The device falls under product code BSY (Catheters, Suction, Tracheobronchial), a Class I device regulated under 21 CFR 868.6810. Sontek Industries, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 27, 1981
- Date Received
- May 4, 1981
- 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