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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K242763
Device Name JetCan® Pro Safety Huber Needle
Applicant
Pfm Medical, Inc.
1916 Palomar Oaks Way
Carlsbad,  CA  92008
Applicant Contact Jessica Jho
Correspondent
Pfm Medical, Inc.
1916 Palomar Oaks Way
Carlsbad,  CA  92008
Correspondent Contact Jessica Jho
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/12/2024
Decision Date 05/02/2025
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
Predetermined Change
Control Plan Authorized		 No
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