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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 K122278
Device Name BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR
Original Applicant
BAYLIS MEDICAL COMPANY INC.
2645 matheson blvd. east
mississauga,  CA l4w 5s4
Original Contact meghal khakhar
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/30/2012
Decision Date 11/07/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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