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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleaner, Air, Medical Recirculating
510(k) Number K953536
Device Name SLANT/FIN HEPA CLEAR
Applicant
Amcor, Ltd.
5-39 46th Ave.
Long Island City,  NY  11101
Applicant Contact BENJAMIN LEVY
Correspondent
Amcor, Ltd.
5-39 46th Ave.
Long Island City,  NY  11101
Correspondent Contact BENJAMIN LEVY
Regulation Number880.5045
Classification Product Code
FRF  
Date Received07/27/1995
Decision Date 10/30/1995
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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