INSURE II— 510(k) K060930

Substantially Equivalent

Enterix, Inc.

FDA 510(k) clearance K060930 for INSURE II, Substantially Equivalent on 2006-05-04. Applicant: Enterix, Inc.. Device class: 2.

Clearance details

Applicant: Enterix, Inc.
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 2006-04-05
Decision date: 2006-05-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Edison, NJ, US

Download summary PDF View on FDA.gov ↗

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More clearances from Enterix, Inc.

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