510(k) K133881
K133881 is an FDA 510(k) premarket notification submitted by Hospi Corporation for the device "MACY CATHETER". The FDA issued a decision of Substantially Equivalent on Jan 24, 2014. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 24, 2014
- Date Received
- Dec 20, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device classification
- Device Name
- Tubes, Gastrointestinal (And Accessories)
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type
- 510(k)