The following data is part of a premarket notification filed by Wallach Surgical Devices, Inc. with the FDA for Wallach's Ultimate Reusable, Plastic Vaginal Speculum.
| Device ID | K992736 |
| 510k Number | K992736 |
| Device Name: | WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM |
| Classification | Speculum, Vaginal, Nonmetal |
| 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 | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-13 |
| Decision Date | 1999-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888937011371 | K992736 | 000 |