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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Caloric-Water
510(k) Number K821481
Device Name NASAL-THROAT SPRAY IRRIGATION INSTRUM.
Applicant
Ethicare Products
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Ethicare Products
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number874.1800
Classification Product Code
ETP  
Date Received05/18/1982
Decision Date 06/14/1982
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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