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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name syringe, piston
510(k) Number K033739
Device Name PHYSICIAN INDUSTRIES' DURAMETER SYRINGE
Applicant
PHYSICIAN INDUSTRIES, INC.
2203 WEST ALEXANDER
SALT LAKE CITY,  UT  84119
Applicant Contact BRIAN BAKER
Correspondent
PHYSICIAN INDUSTRIES, INC.
2203 WEST ALEXANDER
SALT LAKE CITY,  UT  84119
Correspondent Contact BRIAN BAKER
Regulation Number880.5860
Classification Product Code
FMF  
Date Received11/28/2003
Decision Date 07/12/2004
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
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