The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Bakri Essential Postpartum Balloon.
| Device ID | K223098 |
| 510k Number | K223098 |
| Device Name: | Bakri Essential Postpartum Balloon |
| Classification | Intrauterine Tamponade Balloon |
| Applicant | Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 |
| Contact | Ian Herman |
| Correspondent | Ian Herman 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 | 2022-09-30 |
| Decision Date | 2022-10-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10827002590943 | K223098 | 000 |