510(k) K881149
K881149 is an FDA 510(k) premarket notification submitted by Ferguson Medical for the device "MUCUS TRAP OR SUCTION TRAP". The FDA issued a decision of Substantially Equivalent on June 14, 1988. The device falls under product code KDQ (Bottle, Collection, Vacuum), a Class II device regulated under 21 CFR 880.6740. Ferguson Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 14, 1988
- Date Received
- March 17, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bottle, Collection, Vacuum
- Device Class
- Class II
- Regulation Number
- 880.6740
- Review Panel
- HO
- Submission Type