GENT-L-KARE VAGINAL IRRIGATION SET— 510(k) K881216

Name: FDA 510(k) clearance K881216
Creator: U.S. Food and Drug Administration
Published: 1988-06-07

Substantially Equivalent

Geneva Laboratories, Inc.

FDA 510(k) clearance K881216 for GENT-L-KARE VAGINAL IRRIGATION SET, Substantially Equivalent on 1988-06-07. Applicant: Geneva Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Geneva Laboratories, Inc.
Product code: Code HED
Device class: Class 1
Regulation: 21 CFR 884.5900
Advisory panel: Obstetrics/Gynecology
Date received: 1988-03-22
Decision date: 1988-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhorn, WI, US

Download summary PDF View on FDA.gov ↗

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