SINGHMED ROOLIP MANIPULATOR— 510(k) K110819

Name: FDA 510(k) clearance K110819
Creator: U.S. Food and Drug Administration
Published: 2011-10-05

Substantially Equivalent

J.Singh Instruments

FDA 510(k) clearance K110819 for SINGHMED ROOLIP MANIPULATOR, Substantially Equivalent on 2011-10-05. Applicant: J.Singh Instruments. Device class: 2.

Clearance details

Applicant: J.Singh Instruments
Product code: Code HEW
Device class: Class 2
Regulation: 21 CFR 884.1640
Advisory panel: Obstetrics/Gynecology
Date received: 2011-03-23
Decision date: 2011-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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