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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 K960966
Device Name HEPA-TYPE AIR CLEANER MODEL 2586 AND TRUE HEPA AIR CLEANER MODELS 2587 AND 2588
Applicant
Sunbeam-Oster Household Products
95 Wl Runnel Industrial Dr.
Hattiesburg,  MS  39401
Applicant Contact DAVID VANDERLIN
Correspondent
Sunbeam-Oster Household Products
95 Wl Runnel Industrial Dr.
Hattiesburg,  MS  39401
Correspondent Contact DAVID VANDERLIN
Regulation Number880.5045
Classification Product Code
FRF  
Date Received03/11/1996
Decision Date 01/10/1997
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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