The following data is part of a premarket notification filed by Turboseal, L.p. with the FDA for Turboseal Nasogastric Aspiration Tube.
| Device ID | K142483 |
| 510k Number | K142483 |
| Device Name: | TurboSEAL Nasogastric Aspiration Tube |
| Classification | Tube, Nasogastric |
| Applicant | TurboSEAL, L.P. 7 Haarad St Tel Aviv, IL 6971060 |
| Contact | Doron Besser |
| Correspondent | Ian Marsden DOHMEN LIFE SCIENCE SERVICES, LLC 11925 W I-70 FRONTAGE ROAD NORTH, SUITE 900 Wheat Ridge, CO 80033 |
| Product Code | BSS |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-04 |
| Decision Date | 2014-12-19 |
| Summary: | summary |