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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 K991254
Device Name QS DELIVERY SYSTEM
Applicant
Sub-Q, Inc.
1062-D Calle Negocio
San Clemente,  CA  92673
Applicant Contact DAN W MILLER
Correspondent
Sub-Q, Inc.
1062-D Calle Negocio
San Clemente,  CA  92673
Correspondent Contact DAN W MILLER
Regulation Number880.6960
Classification Product Code
KYZ  
Date Received04/13/1999
Decision Date 08/23/1999
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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