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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Angiographic
510(k) Number K853044
Device Name STERICOVER
Applicant
Sterimed, Inc.
P.O. Box #686
Acworth,  GA  30101
Applicant Contact BRUCE R GRADY
Correspondent
Sterimed, Inc.
P.O. Box #686
Acworth,  GA  30101
Correspondent Contact BRUCE R GRADY
Regulation Number892.1600
Classification Product Code
IZI  
Date Received07/19/1985
Decision Date 11/01/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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