SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD— 510(k) K965187

Name: FDA 510(k) clearance K965187
Creator: U.S. Food and Drug Administration
Published: 1997-08-01

Substantially Equivalent

Sparta Surgical Corp.

FDA 510(k) clearance K965187 for SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD, Substantially Equivalent on 1997-08-01. Applicant: Sparta Surgical Corp.. Device class: 2.

Clearance details

Applicant: Sparta Surgical Corp.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1996-12-24
Decision date: 1997-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck,, NY, US

Download summary PDF View on FDA.gov ↗

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