VAGINAL CHAMBER PELLETHANE-MEDICAL GRADE 2363— 510(k) K861858

Name: FDA 510(k) clearance K861858
Creator: U.S. Food and Drug Administration
Published: 1986-07-31

Substantially Equivalent

Peritone Research, Ltd.

FDA 510(k) clearance K861858 for VAGINAL CHAMBER PELLETHANE-MEDICAL GRADE 2363, Substantially Equivalent on 1986-07-31. Applicant: Peritone Research, Ltd.. Device class: 2.

Clearance details

Applicant: Peritone Research, Ltd.
Product code: Code HIR
Device class: Class 2
Regulation: 21 CFR 884.1425
Advisory panel: Obstetrics/Gynecology
Date received: 1986-05-14
Decision date: 1986-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellerose, NY, US

Download summary PDF View on FDA.gov ↗

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