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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
Applicant
HAYMAX LIMITED
POSTERN PIECE FARM
BEDFORD STREET
AMPTHILL, BEDFORDSHIRE,  GB MK45 2EX
Applicant Contact MAX WISEBERG
Correspondent
HAYMAX LIMITED
POSTERN PIECE FARM
BEDFORD STREET
AMPTHILL, BEDFORDSHIRE,  GB MK45 2EX
Correspondent Contact MAX WISEBERG
Regulation Number880.5045
Classification Product Code
NUP  
Date Received03/23/2012
Decision Date 05/17/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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