MONSANTO SANTOPRENE (PERITONE DEVICE)— 510(k) K861683

Name: FDA 510(k) clearance K861683
Creator: U.S. Food and Drug Administration
Published: 1986-06-02

Substantially Equivalent

Peritone Research, Ltd.

FDA 510(k) clearance K861683 for MONSANTO SANTOPRENE (PERITONE DEVICE), Substantially Equivalent on 1986-06-02. 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: 1986-05-01
Decision date: 1986-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellerose, NY, US

Download summary PDF View on FDA.gov ↗

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