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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Antistick
510(k) Number K031065
Device Name SYRINGEX SAFETY SYRINGE, MODEL 0322G1.5
Applicant
Syringex Medical, Inc.
2311 Bear Hills Ct.
Draper,  UT  84020
Applicant Contact JOHN JONES
Correspondent
Syringex Medical, Inc.
2311 Bear Hills Ct.
Draper,  UT  84020
Correspondent Contact JOHN JONES
Regulation Number880.5860
Classification Product Code
MEG  
Subsequent Product Code
FMF  
Date Received04/03/2003
Decision Date 06/23/2003
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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