OCTOTMPORT— 510(k) K112196

Substantially Equivalent

Dalim Surgnet Corporation

FDA 510(k) clearance K112196 for OCTOTMPORT, Substantially Equivalent on 2011-09-14. Applicant: Dalim Surgnet Corporation. Device class: 2.

Clearance details

Applicant: Dalim Surgnet Corporation
Product code: Code OTJ
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2011-08-01
Decision date: 2011-09-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Brea, CA, 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.