The following data is part of a premarket notification filed by Cook Ob/gyn with the FDA for Sholkoff Balloon Hysterosalpingography Catheter.
| Device ID | K891290 |
| 510k Number | K891290 |
| Device Name: | SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER |
| Classification | Insufflator, Carbon-dioxide, Uterotubal (and Accessories) |
| Applicant | COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
| Contact | Michelle Young |
| Correspondent | Michelle Young COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
| Product Code | HES |
| CFR Regulation Number | 884.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-10 |
| Decision Date | 1989-05-23 |