The following data is part of a premarket notification filed by Spiration, Inc. with the FDA for B7 2c Occlusion Balloon.
| Device ID | K171492 |
| 510k Number | K171492 |
| Device Name: | B7 2C Occlusion Balloon |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | Spiration, Inc. 6675 185th Avenue N.E. Redmond, WA 98052 |
| Contact | Cheryl Frederick |
| Correspondent | Cheryl Frederick Spiration, Inc. 6675 185th Avenue N.E. 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 | 2017-05-22 |
| Decision Date | 2017-11-20 |
| Summary: | summary |