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510(k) K792687

Device
ASPERGILLUS SP., ANTIGEN
Applicant
MERIDIAN DIAGNOSTICS, INC.
510(k) number
K792687
Product code
JWI  
Decision
Substantially Equivalent (SESE)
Decision date
1980-01-17
Date received
1979-12-27
Regulation
888.3800
Classification name
Prosthesis, Wrist, 2 Part Metal-plastic Articulation, Semi-constrained
Medical specialty
Orthopedic
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JWI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K931265FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2NDFerguson Medical1995-05-22
K940297UNIVERSAL WRISTTurnkey Intergration USA, Inc.1995-02-06

Legacy Summary#

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FDA Review#

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