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510(k) K894455

Device
DECONTAMINATING KIT, SKIN: M291
Applicant
DEPT. OF THE ARMY
510(k) number
K894455
Product code
MAC  
Decision
Substantially Equivalent (SESE)
Decision date
1989-08-15
Date received
1989-07-25
Regulation
878.4014
Classification name
Decontamination Kit
Medical specialty
General & Plastic Surgery
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
RONALD E CLAWSON
Address
Mater Devel Activity Sgrd-Ump Fort Detrick Frederick MD US 21701 21701

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MAC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K023969REACTIVE SKIN DECONTAMINATION LOTIONDept. of the Army2003-03-25

Legacy Summary#

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FDA Review#

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