The following data is part of a premarket notification filed by Spiration, Inc. with the FDA for Flexible 19g Ebus Needle.
| Device ID | K142909 |
| 510k Number | K142909 |
| Device Name: | Flexible 19G EBUS Needle |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | SPIRATION, INC. 6675 185TH AVENUE NE Redmond, WA 98052 |
| Contact | Cyndy J Adams |
| Correspondent | Cyndy J Adams SPIRATION, INC. 6675 185TH AVENUE NE Redmond, WA 98052 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-06 |
| Decision Date | 2015-04-24 |
| Summary: | summary |