IMPLANT SCIENCES CORP. MODEL HDR 4454— 510(k) K070468

Name: FDA 510(k) clearance K070468
Creator: U.S. Food and Drug Administration
Published: 2007-03-23

Substantially Equivalent

Implant Sciences Corp.

FDA 510(k) clearance K070468 for IMPLANT SCIENCES CORP. MODEL HDR 4454, Substantially Equivalent on 2007-03-23. Applicant: Implant Sciences Corp.. Device class: 2.

Clearance details

Applicant: Implant Sciences Corp.
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 2007-02-16
Decision date: 2007-03-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Wakefield, MA, US

Download summary PDF View on FDA.gov ↗

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