QUANTROLS RF— 510(k) K771940

Substantially Equivalent

Organon, Inc.

FDA 510(k) clearance K771940 for QUANTROLS RF, Substantially Equivalent on 1977-11-02. Applicant: Organon, Inc.. Device class: 2.

Clearance details

Applicant
Organon, Inc.
Product code
Code DHR
Device class
Class 2
Regulation
21 CFR 866.5775
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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