LAPAROFLATOR 3000, STANDARD AND ELECTRONIC— 510(k) K875137

Name: FDA 510(k) clearance K875137
Creator: U.S. Food and Drug Administration
Published: 1988-03-02

Substantially Equivalent

F.M. Wiest USA, Inc.

FDA 510(k) clearance K875137 for LAPAROFLATOR 3000, STANDARD AND ELECTRONIC, Substantially Equivalent on 1988-03-02. Applicant: F.M. Wiest USA, Inc.. Device class: 2.

Clearance details

Applicant: F.M. Wiest USA, Inc.
Product code: Code HES
Device class: Class 2
Regulation: 21 CFR 884.1300
Advisory panel: Obstetrics/Gynecology
Date received: 1987-12-15
Decision date: 1988-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cherry Hill, NJ, US

Download summary PDF View on FDA.gov ↗

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