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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 K110814
Device Name AMBIT TUNNELER
Applicant
Summit Medical Products, Inc.
2480 S. Main St.
#212
Salt Lake City,  UT  84118
Applicant Contact MARKO V AMEN
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number868.5120
Classification Product Code
BSO  
Date Received03/24/2011
Decision Date 04/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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