The following data is part of a premarket notification filed by Wallach Surgical Devices, Inc. with the FDA for `the Inseminator' (proposed).
| Device ID | K984306 |
| 510k Number | K984306 |
| Device Name: | `THE INSEMINATOR' (PROPOSED) |
| Classification | Cannula, Intrauterine Insemination |
| Applicant | WALLACH SURGICAL DEVICES, INC. 235 EDISON RD. Orange, CT 06477 |
| Contact | Michael Malis |
| Correspondent | Michael Malis WALLACH SURGICAL DEVICES, INC. 235 EDISON RD. Orange, CT 06477 |
| Product Code | MFD |
| CFR Regulation Number | 884.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-02 |
| Decision Date | 1999-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888937011494 | K984306 | 000 |
| 20888937011481 | K984306 | 000 |
| 20888937011474 | K984306 | 000 |