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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name saline, vascular access flush
510(k) Number K121262
Device Name MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY
Original Applicant
MEDEFIL, INC.
250 windy point dr.
glendale heights,  IL  60139
Original Contact pradeep aggarwal
Regulation Number880.5200
Classification Product Code
NGT  
Date Received04/26/2012
Decision Date 09/20/2012
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
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