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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-Air
510(k) Number K941325
Device Name WATER IRRIGATOR, W1 200
Applicant
Strong Medical, Inc.
St. X, Industrial Area
Heraklion,  GR
Applicant Contact PAUL MCAFEE
Correspondent
Strong Medical, Inc.
St. X, Industrial Area
Heraklion,  GR
Correspondent Contact PAUL MCAFEE
Regulation Number874.1800
Classification Product Code
KHH  
Date Received03/18/1994
Decision Date 08/09/1994
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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