The following data is part of a premarket notification filed by Rinovum Women's Health, Inc with the FDA for The Stork Otc.
| Device ID | K140186 |
| 510k Number | K140186 |
| Device Name: | THE STORK OTC |
| Classification | Kit, Conception-assist, Home Use |
| Applicant | RINOVUM WOMEN'S HEALTH, INC 300 Oxford Dr Suite 330 Monroeville, PA 15146 |
| Contact | Andrew Zeltwanger |
| Correspondent | Andrew Zeltwanger RINOVUM WOMEN'S HEALTH, INC 300 Oxford Dr Suite 330 Monroeville, PA 15146 |
| Product Code | OBB |
| CFR Regulation Number | 884.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-24 |
| Decision Date | 2014-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810396020335 | K140186 | 000 |
| 00810396020311 | K140186 | 000 |
| 00810396020304 | K140186 | 000 |
| 00810396020199 | K140186 | 000 |
| 00810396020090 | K140186 | 000 |
| 00810396020083 | K140186 | 000 |
| 00810396020007 | K140186 | 000 |