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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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More FDA Info for this Product Code
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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