FDA 510(k) Application Details - K170158

Device Classification Name

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510(K) Number K170158
Device Name PowerGlide ST Midline Catheter
Applicant C. R. Bard, Inc.
605 North 5600 West
Salt Lake City, UT 84116 US
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Contact JACOB LEE
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Regulation Number

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Classification Product Code PND
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Date Received 01/18/2017
Decision Date 06/01/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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