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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 K945161
Device Name NORELCO CLEAN AIR SYSTEM CAS950
Applicant
Hogan & Hartson
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact HOWARD M HOLSTEIN
Correspondent
Hogan & Hartson
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number880.5045
Classification Product Code
FRF  
Date Received10/17/1994
Decision Date 11/28/1994
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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