The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Bakri Postpartum Balloon, Bakri Postpartum Balloon With Rapid Instillation Component.
| Device ID | K170622 |
| 510k Number | K170622 |
| Device Name: | Bakri Postpartum Balloon, Bakri Postpartum Balloon With Rapid Instillation Component |
| Classification | Intrauterine Tamponade Balloon |
| Applicant | Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 |
| Contact | Naomi Funkhouser |
| Correspondent | Naomi Funkhouser Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 |
| Product Code | OQY |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-01 |
| Decision Date | 2017-03-31 |
| Summary: | summary |