The following data is part of a premarket notification filed by Boehringer Laboratories, Llc with the FDA for Boehringer Gastric Sizing Tube.
| Device ID | K130483 |
| 510k Number | K130483 |
| Device Name: | BOEHRINGER GASTRIC SIZING TUBE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | BOEHRINGER LABORATORIES, LLC 300 Thoms Drive Phoenixville, PA 19460 |
| Contact | Christopher Radl, Engineering |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-02-25 |
| Decision Date | 2013-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816286020871 | K130483 | 000 |
| 10816286020611 | K130483 | 000 |
| 10816286020628 | K130483 | 000 |
| 30816286020639 | K130483 | 000 |
| 30816286020646 | K130483 | 000 |
| 30816286020653 | K130483 | 000 |
| 30816286020820 | K130483 | 000 |
| 30816286020837 | K130483 | 000 |
| 30816286020844 | K130483 | 000 |
| 30816286020851 | K130483 | 000 |
| 30816286020868 | K130483 | 000 |
| 30816286020592 | K130483 | 000 |
| 30816286020738 | K130483 | 000 |
| 10816286020741 | K130483 | 000 |
| 30816286020608 | K130483 | 000 |