PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS— 510(k) K032119

Name: FDA 510(k) clearance K032119
Creator: U.S. Food and Drug Administration
Published: 2003-10-29

Substantially Equivalent

Paragon Medical, Inc.

FDA 510(k) clearance K032119 for PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS, Substantially Equivalent on 2003-10-29. Applicant: Paragon Medical, Inc.. Device class: 2.

Clearance details

Applicant: Paragon Medical, Inc.
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2003-07-09
Decision date: 2003-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Wayne, IN, US

Download summary PDF View on FDA.gov ↗

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