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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K072487
Device Name FAST1 INTRAOSSEOUS INFUSION SYSTEM
Applicant
Pyng Medical Corp.
#7-13511 Crestwood Pl.
Richmond, B.C.,  CA V6V 2E9
Applicant Contact MAYA BUTTERFIELD
Correspondent
Pyng Medical Corp.
#7-13511 Crestwood Pl.
Richmond, B.C.,  CA V6V 2E9
Correspondent Contact MAYA BUTTERFIELD
Regulation Number880.5570
Classification Product Code
FMI  
Date Received09/04/2007
Decision Date 02/13/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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