FDA 510(k) Application Details - K110814

Device Classification Name Catheter, Conduction, Anesthetic

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510(K) Number K110814
Device Name Catheter, Conduction, Anesthetic
Applicant SUMMIT MEDICAL PRODUCTS, INC
2480 SOUTH MAIN STREET
#212
SALT LAKE CITY, UT 84118 US
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Contact MARKO V AMEN
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Regulation Number 868.5120

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Classification Product Code BSO
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Date Received 03/24/2011
Decision Date 04/08/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party Y
Expedited Review



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