CELL SWEEP— 510(k) K911327

Name: FDA 510(k) clearance K911327
Creator: U.S. Food and Drug Administration
Published: 1991-05-21

Substantially Equivalent

Reza S Mohajer, M.D. C/O Krass & Young

FDA 510(k) clearance K911327 for CELL SWEEP, Substantially Equivalent on 1991-05-21. Applicant: Reza S Mohajer, M.D. C/O Krass & Young. Device class: 2.

Clearance details

Applicant: Reza S Mohajer, M.D. C/O Krass & Young
Product code: Code HHT
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1991-03-26
Decision date: 1991-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Troy, MI, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.