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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 K930860
Device Name HEPA 2500 AIR CLEANER
Applicant
Trion, Inc.
101 Mcneill Rd.
P.O. Box 760
Sanford,  NC  27331
Applicant Contact CRAIG ELLIS
Correspondent
Trion, Inc.
101 Mcneill Rd.
P.O. Box 760
Sanford,  NC  27331
Correspondent Contact CRAIG ELLIS
Regulation Number880.5045
Classification Product Code
FRF  
Date Received02/18/1993
Decision Date 12/22/1993
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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