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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 K982435
Device Name IRRIGATION SYRINGE KIT
Applicant
Sub-Q, Inc.
1062-D Calle Negocio
San Clemente,  CA  92673
Applicant Contact VAUGHAN P WHALEN
Correspondent
Sub-Q, Inc.
1062-D Calle Negocio
San Clemente,  CA  92673
Correspondent Contact VAUGHAN P WHALEN
Regulation Number880.6960
Classification Product Code
KYZ  
Date Received07/13/1998
Decision Date 11/06/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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