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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 K861299
Device Name HYGIENIC AIR PURIFYING DEVICE
Applicant
Puridyne, Inc./Imutech, Inc.
282 W. Millbrook Rd.
Raleigh,  NC  27609
Applicant Contact PAGE, PH.D
Correspondent
Puridyne, Inc./Imutech, Inc.
282 W. Millbrook Rd.
Raleigh,  NC  27609
Correspondent Contact PAGE, PH.D
Regulation Number880.5045
Classification Product Code
FRF  
Date Received04/07/1986
Decision Date 07/23/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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