510(k) K955150
K955150 is an FDA 510(k) premarket notification submitted by Bio-Medical Devices, Inc. for the device "MAXI-FLOW". The FDA issued a decision of Substantially Equivalent on January 23, 1996. The device falls under product code BYY (Tube, Aspirating, Flexible, Connecting), a Class II device regulated under 21 CFR 880.6740. Bio-Medical Devices, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 1996
- Date Received
- November 13, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Aspirating, Flexible, Connecting
- Device Class
- Class II
- Regulation Number
- 880.6740
- Review Panel
- HO
- Submission Type