NEPHRETECT— 510(k) K934066

Substantially Equivalent

Alden Scientific, Inc.

FDA 510(k) clearance K934066 for NEPHRETECT, Substantially Equivalent on 1995-05-02. Applicant: Alden Scientific, Inc.. Device class: 2.

Clearance details

Applicant: Alden Scientific, Inc.
Product code: Product code JOJ
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 1993-08-20
Decision date: 1995-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winthrop, MA, US

Download summary PDF View on FDA.gov ↗

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