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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
Recalls CDRH Recalls
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