510(k) K791253
K791253 is an FDA 510(k) premarket notification submitted by Conphar, Inc. for the device "CONPHAR SUCTION CATHETER-W/0 CONTROL". The FDA issued a decision of Substantially Equivalent on Jul 30, 1979. The device falls under product code BSY (Catheters, Suction, Tracheobronchial), a Class I device regulated under 21 CFR 868.6810. Conphar, Inc. has 121 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 30, 1979
- Date Received
- Jul 6, 1979
- 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
- 510(k) Exempt