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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 K010265
Device Name BAYLIS MEDICAL RF PERFORATION PROBE, MODEL RFP-265
Applicant
BAYLIS MEDICAL CO., INC.
5160 EXPLORER DRIVE, UNIT 33
MISSISSAUGA, ONTARIO,  CA L4W-4T7
Applicant Contact KRIS SHAH
Correspondent
BAYLIS MEDICAL CO., INC.
5160 EXPLORER DRIVE, UNIT 33
MISSISSAUGA, ONTARIO,  CA L4W-4T7
Correspondent Contact KRIS SHAH
Regulation Number878.4400
Classification Product Code
GEI  
Date Received01/26/2001
Decision Date 04/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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