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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 K932803
Device Name CLESTRACLEAN(R) ROOM AIR PURIFIER
Applicant
Clestra Cleanroom Technology, Inc.
Performance Dr.
Syracuse,  NY  13212
Applicant Contact JOHN BRECKENRIDGE
Correspondent
Clestra Cleanroom Technology, Inc.
Performance Dr.
Syracuse,  NY  13212
Correspondent Contact JOHN BRECKENRIDGE
Regulation Number880.6500
Classification Product Code
FRA  
Date Received06/09/1993
Decision Date 05/12/1994
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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