COVERSAN, ISLESAN— 510(k) K952547

Name: FDA 510(k) clearance K952547
Creator: U.S. Food and Drug Administration
Published: 1995-08-14

Substantially Equivalent

Medical Device Development Co.

FDA 510(k) clearance K952547 for COVERSAN, ISLESAN, Substantially Equivalent on 1995-08-14. Applicant: Medical Device Development Co.. Device class: 1.

Clearance details

Applicant: Medical Device Development Co.
Product code: Code KMF
Device class: Class 1
Regulation: 21 CFR 880.5090
Advisory panel: General Hospital
Date received: 1995-06-02
Decision date: 1995-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morris Plains, NY, US

Download summary PDF View on FDA.gov ↗

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