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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 K960248
Device Name GENERAL PROCEDURE KIT
Applicant
PHYSICIAN INDUSTRIES, INC.
101 NORTH 700 WST
P.O. BOX 540793
NORTH SALT LAKE,  UT  84054 -0793
Applicant Contact BRIAN BAKER
Correspondent
PHYSICIAN INDUSTRIES, INC.
101 NORTH 700 WST
P.O. BOX 540793
NORTH SALT LAKE,  UT  84054 -0793
Correspondent Contact BRIAN BAKER
Regulation Number880.5860
Classification Product Code
FMF  
Date Received01/16/1996
Decision Date 04/12/1996
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
Recalls CDRH Recalls
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