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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 K900208
Device Name ZEROWET SPLASHIELD
Applicant
Zerowet Splashield
1715 Via El Prado
P.O. Box 7000-16
Redondo Beach,  CA  90277
Applicant Contact STAMLER, MD
Correspondent
Zerowet Splashield
1715 Via El Prado
P.O. Box 7000-16
Redondo Beach,  CA  90277
Correspondent Contact STAMLER, MD
Regulation Number880.6960
Classification Product Code
KYZ  
Date Received01/17/1990
Decision Date 09/04/1990
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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