MANIPUSEAL— 510(k) K051160

Substantially Equivalent

Insitu Systems

FDA 510(k) clearance K051160 for MANIPUSEAL, Substantially Equivalent on 2005-09-02. Applicant: Insitu Systems. Device class: 2.

Clearance details

Applicant: Insitu Systems
Product code: Code HEW
Device class: Class 2
Regulation: 21 CFR 884.1640
Advisory panel: Obstetrics/Gynecology
Date received: 2005-05-05
Decision date: 2005-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.