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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 K842973
Device Name HAYFEVER HELMET
Applicant
R.H. Hinchli Fle & Sons, Ltd.
39 High St.
Worcestershire,  55243
Applicant Contact HINCHLIFFE
Correspondent
R.H. Hinchli Fle & Sons, Ltd.
39 High St.
Worcestershire,  55243
Correspondent Contact HINCHLIFFE
Regulation Number880.5045
Classification Product Code
FRF  
Date Received07/30/1984
Decision Date 10/25/1984
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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