The following data is part of a premarket notification filed by Cook Ob/gyn with the FDA for Bakri Postpartum Balloon, Model J-sos-100500.
| Device ID | K062438 |
| 510k Number | K062438 |
| Device Name: | BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 |
| Classification | Instrument, Manual, Specialized Obstetric-gynecologic |
| Applicant | COOK OB/GYN 1100 WEST MORGAN STREET Spencer, IN 47460 |
| Contact | Cindy Rumple |
| Correspondent | Cindy Rumple COOK OB/GYN 1100 WEST MORGAN STREET Spencer, IN 47460 |
| Product Code | KNA |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-21 |
| Decision Date | 2006-10-27 |
| Summary: | summary |