RECONSTITUTION ACCESSOREIS— 510(k) K950861

Substantially Equivalent

Organon, Inc.

FDA 510(k) clearance K950861 for RECONSTITUTION ACCESSOREIS, Substantially Equivalent on 1995-05-26. Applicant: Organon, Inc.. Device class: 2.

Clearance details

Applicant
Organon, Inc.
Product code
Code FPK
Device class
Class 2
Regulation
21 CFR 880.5440
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
West Orange, NJ, US
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