WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM— 510(k) K992736

Name: FDA 510(k) clearance K992736
Creator: U.S. Food and Drug Administration
Published: 1999-09-29

Substantially Equivalent

Wallach Surgical Devices, Inc.

FDA 510(k) clearance K992736 for WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM, Substantially Equivalent on 1999-09-29. Applicant: Wallach Surgical Devices, Inc.. Device class: 2.

Clearance details

Applicant: Wallach Surgical Devices, Inc.
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1999-08-13
Decision date: 1999-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, CT, US

Download summary PDF View on FDA.gov ↗

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