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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
Models REP-100A, RFA-FS
Device Name BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR
Applicant
BAYLIS MEDICAL COMPANY INC.
2645 matheson blvd. east
mississauga, 
Contact meghal khakhar
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/30/2012
Decision Date 11/07/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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