510(k) K130483
K130483 is an FDA 510(k) premarket notification submitted by Boehringer Laboratories, LLC for the device "BOEHRINGER GASTRIC SIZING TUBE". The FDA issued a decision of Substantially Equivalent on Mar 28, 2013. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Boehringer Laboratories, LLC has 43 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 28, 2013
- Date Received
- Feb 25, 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)