ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT— 510(k) K121604

Name: FDA 510(k) clearance K121604
Creator: U.S. Food and Drug Administration
Published: 2012-07-27

Substantially Equivalent

Obp Corporation

FDA 510(k) clearance K121604 for ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT, Substantially Equivalent on 2012-07-27. Applicant: Obp Corporation. Device class: 2.

Clearance details

Applicant: Obp Corporation
Product code: Code FER
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2012-06-01
Decision date: 2012-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lawerence, MA, US

Download summary PDF View on FDA.gov ↗

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