510(k) K132314
K132314 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "MEDLINE ANTI-REFLUX VALVE". The FDA issued a decision of Substantially Equivalent on September 18, 2013. The device falls under product code FEG (Tube, Double Lumen For Intestinal Decompression And/Or Intubation), a Class II device regulated under 21 CFR 876.5980. Medline Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 18, 2013
- Date Received
- July 25, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Double Lumen For Intestinal Decompression And/Or Intubation
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type