510(k) K760427
K760427 is an FDA 510(k) premarket notification submitted by Will Ross Co. for the device "CATHETER, DOVER SUCTION W/ GLOVE". The FDA issued a decision of Substantially Equivalent on September 9, 1976. The device falls under product code BSY (Catheters, Suction, Tracheobronchial), a Class I device regulated under 21 CFR 868.6810. Will Ross Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 1976
- Date Received
- August 13, 1976
- 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