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 |