The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Through The -peg (ttp) Jejunal Feeding Tube Kit, Model M00566320,m00566330, M00566340, M00566350.
| Device ID | K091340 |
| 510k Number | K091340 |
| Device Name: | THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350 |
| Classification | Tube, Feeding |
| Applicant | BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Contact | Marybeth Gamber |
| Correspondent | Marybeth Gamber BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Product Code | FPD |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-06 |
| Decision Date | 2009-06-09 |
| Summary: | summary |