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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hood, Surgical
510(k) Number K904969
Device Name HOOD, OPERATING, SURGICAL
Applicant
Chicago Assoc. For Retarded Citizens
8 S. Michigan Ave.
Chicago,  IL  60603
Applicant Contact MARY ZUBEK
Correspondent
Chicago Assoc. For Retarded Citizens
8 S. Michigan Ave.
Chicago,  IL  60603
Correspondent Contact MARY ZUBEK
Regulation Number878.4040
Classification Product Code
FXY  
Date Received11/05/1990
Decision Date 12/12/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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