CYTETTE(TM) CYTOLOGY BRUSH— 510(k) K902591

Name: FDA 510(k) clearance K902591
Creator: U.S. Food and Drug Administration
Published: 1990-09-10

Substantially Equivalent

Birchwood Laboratories, Inc.

FDA 510(k) clearance K902591 for CYTETTE(TM) CYTOLOGY BRUSH, Substantially Equivalent on 1990-09-10. Applicant: Birchwood Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Birchwood Laboratories, Inc.
Product code: Code HHT
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1990-06-12
Decision date: 1990-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

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