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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 K925566
Device Name HOLMES AIR PURIFIER MODELS HAP-240 & HAP-300
Applicant
HOLMES PRODUCTS CORP.
233 FORTUNE BLVD.
GRANITE PARK
MILFORD,  MA  01757
Applicant Contact NEVILLE R GLENN
Correspondent
HOLMES PRODUCTS CORP.
233 FORTUNE BLVD.
GRANITE PARK
MILFORD,  MA  01757
Correspondent Contact NEVILLE R GLENN
Regulation Number880.5045
Classification Product Code
FRF  
Date Received11/03/1992
Decision Date 03/17/1994
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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