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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K132374
Device Name BAYLIS MEDICAL RF PERFORATION PROBE V2.0
Applicant
Baylis Medical Company, Inc.
2645 Matheson Blvd. E.
Mississauga, Ontario,  CA L4W 5S4
Applicant Contact MEGHAL KHAKHAR
Correspondent
Baylis Medical Company, Inc.
2645 Matheson Blvd. E.
Mississauga, Ontario,  CA L4W 5S4
Correspondent Contact MEGHAL KHAKHAR
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/30/2013
Decision Date 08/30/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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