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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Irrigator, Powered Nasal
510(k) Number K822351
Device Name POWDER BLOWERS
Applicant
KELLEHER CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
KELLEHER CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number874.5550
Classification Product Code
KMA  
Date Received08/06/1982
Decision Date 09/14/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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