The following data is part of a premarket notification filed by Milex Products, Inc. with the FDA for Inflat-o-ball.
| Device ID | K904026 |
| 510k Number | K904026 |
| Device Name: | INFLAT-O-BALL |
| Classification | Pessary, Vaginal |
| Applicant | MILEX PRODUCTS, INC. 5915 NORTHWEST HIGHWAY Chicago, IL 60631 |
| Contact | Gary Chuven |
| Correspondent | Gary Chuven MILEX PRODUCTS, INC. 5915 NORTHWEST HIGHWAY Chicago, IL 60631 |
| Product Code | HHW |
| CFR Regulation Number | 884.3575 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-30 |
| Decision Date | 1990-10-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888937008067 | K904026 | 000 |
| 00888937012538 | K904026 | 000 |
| 00888937012545 | K904026 | 000 |
| 00888937012552 | K904026 | 000 |
| 00888937012569 | K904026 | 000 |
| 00888937012576 | K904026 | 000 |
| 00888937012583 | K904026 | 000 |
| 00888937012590 | K904026 | 000 |
| 00888937012606 | K904026 | 000 |
| 00888937012521 | K904026 | 000 |
| 00888937012514 | K904026 | 000 |
| 00888937008074 | K904026 | 000 |
| 00888937008081 | K904026 | 000 |
| 00888937008098 | K904026 | 000 |
| 00888937012460 | K904026 | 000 |
| 00888937012477 | K904026 | 000 |
| 00888937012484 | K904026 | 000 |
| 00888937012491 | K904026 | 000 |
| 00888937012507 | K904026 | 000 |
| 00888937012620 | K904026 | 000 |
| 00888937012637 | K904026 | 000 |
| 00888937012644 | K904026 | 000 |
| 60888937008236 | K904026 | 000 |
| 60888937008243 | K904026 | 000 |
| 60888937008250 | K904026 | 000 |
| 60888937008267 | K904026 | 000 |
| 60888937008274 | K904026 | 000 |
| 60888937008281 | K904026 | 000 |
| 60888937008298 | K904026 | 000 |
| 60888937008304 | K904026 | 000 |
| 60888937008137 | K904026 | 000 |
| 60888937008120 | K904026 | 000 |
| 00888937012651 | K904026 | 000 |
| 00888937012668 | K904026 | 000 |
| 00888937012675 | K904026 | 000 |
| 00888937012682 | K904026 | 000 |
| 00888937012699 | K904026 | 000 |
| 00888937012705 | K904026 | 000 |
| 00888937012712 | K904026 | 000 |
| 60888937008106 | K904026 | 000 |
| 60888937008311 | K904026 | 000 |