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 |