EMBRACE GEL— 510(k) K072515

Substantially Equivalent

Orison Corporation

FDA 510(k) clearance K072515 for EMBRACE GEL, Substantially Equivalent on 2007-09-20. Applicant: Orison Corporation. Device class: 2.

Clearance details

Applicant: Orison Corporation
Product code: Code MUI
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 2007-09-07
Decision date: 2007-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Johnson City, TN, 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.