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510(k) K920406

Device
DECOMAT 228
Applicant
GETINGE INTERNATIONAL, INC.
510(k) number
K920406
Product code
MDZ  
Decision
Substantially Equivalent (SESE)
Decision date
1994-04-05
Date received
1992-01-31
Regulation
880.6992
Classification name
Cleaners, Medical Devices
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
PAUL RODRIGUEZ
Address
1100 Towbin Ave. Lakewood NJ US 08701 08701

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MDZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K920413DECOMAT A 8666Getinge International, Inc.1994-04-05

Legacy Summary#

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FDA Review#

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