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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Purifier, Air, Ultraviolet, Medical
510(k) Number K972064
Device Name MICROCON 800MUV, MICROCON 400MUV, MICROCON EXC-BUV
Applicant
Biological Controls, Inc.
One Industrial Way W.
Bldg. E, Unit M
Eatontown,  NJ  07724
Applicant Contact GARY D MESSINA
Correspondent
Biological Controls, Inc.
One Industrial Way W.
Bldg. E, Unit M
Eatontown,  NJ  07724
Correspondent Contact GARY D MESSINA
Regulation Number880.6500
Classification Product Code
FRA  
Date Received06/03/1997
Decision Date 12/01/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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