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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Steam
510(k) Number K903096
Device Name RACK-IT (R)
Applicant
VENGO INDUSTRIES, INC.
10119 COLONIAL INDUSTRIAL DR.
SOUTH LYON,  MI  48178
Applicant Contact CHOATE, JR.
Correspondent
VENGO INDUSTRIES, INC.
10119 COLONIAL INDUSTRIAL DR.
SOUTH LYON,  MI  48178
Correspondent Contact CHOATE, JR.
Regulation Number880.6880
Classification Product Code
FLE  
Date Received07/13/1990
Decision Date 10/01/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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