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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, conduction, anesthetic
510(k) Number K102460
Device Name AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH
Applicant
SUMMIT MEDICAL PRODUCTS, INC
2480 SOUTH MAIN STREET
SALT LAKE CITY,  UT  84115
Applicant Contact MARKO VAN AMEN
Correspondent
SUMMIT MEDICAL PRODUCTS, INC
2480 SOUTH MAIN STREET
SALT LAKE CITY,  UT  84115
Correspondent Contact MARKO VAN AMEN
Regulation Number868.5120
Classification Product Code
BSO  
Date Received08/27/2010
Decision Date 01/13/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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