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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 K072345
Device Name POWRSYRINGE MONITOR
Applicant
Pinyons Medical Technology, Inc.
5010 Heuga Ct.
Park City,  UT  84098
Applicant Contact SHAWN P FOJTIK
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number880.5860
Classification Product Code
FMF  
Date Received08/21/2007
Decision Date 09/21/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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