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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 K974288
Device Name ZEROWET SPLASHIELD
Applicant
Zerowet, Inc.
P.O. Box 4375
Palos Verdes Peninsula,  CA  90274
Applicant Contact KEITH STAMLER
Correspondent
Zerowet, Inc.
P.O. Box 4375
Palos Verdes Peninsula,  CA  90274
Correspondent Contact KEITH STAMLER
Regulation Number880.6960
Classification Product Code
KYZ  
Date Received11/14/1997
Decision Date 01/29/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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