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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biopsy Needle
510(k) Number K140137
Device Name SAFETY BIOPSY NEEDLE SYSTEM
Applicant
PFM MEDICAL, INC
1815 ASTON AVE, SUITE 106
CARLSBAD,  CA  92008
Applicant Contact SALVADORE PALOMARES
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number876.1075
Classification Product Code
FCG  
Date Received01/22/2014
Decision Date 03/25/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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