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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cream, nasal, topical, mechanical allergen particle barrier
510(k) Number K120894
Device Name HAYMAX
Original Applicant
HAYMAX LIMITED
postern piece farm
bedford street
ampthill, bedfordshire,  UK mk45 2ex
Original Contact max wiseberg
Regulation Number880.5045
Classification Product Code
NUP  
Date Received03/23/2012
Decision Date 05/17/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee Ear Nose & Throat
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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