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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K192247
Device Name Steripath Gen2 Blood Collection System
Applicant
Magnolia Medical Technologies, Inc.
200 W Mercer St. Suite 500
Seattle,  WA  98119
Applicant Contact Gregory J Bullington
Correspondent
Magnolia Medical Technologies, Inc.
200 W Mercer St. Suite 500
Seattle,  WA  98119
Correspondent Contact John Ray
Regulation Number862.1675
Classification Product Code
JKA  
Subsequent Product Code
FPA  
Date Received08/19/2019
Decision Date 02/28/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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