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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Irrigating (Non Dental)
510(k) Number K905173
Device Name SPLASH GUARD
Applicant
E.M. Adams
121 W. St.
Medfield,  MA  02052
Applicant Contact RICHARD K DONAHUE
Correspondent
E.M. Adams
121 W. St.
Medfield,  MA  02052
Correspondent Contact RICHARD K DONAHUE
Regulation Number880.6960
Classification Product Code
KYZ  
Date Received11/16/1990
Decision Date 04/25/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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