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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Septostomy
510(k) Number K990284
Device Name BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE
Applicant
Baylis Medical Co., Inc.
5160 Explorer Dr., Unit 5
Mississauga,  CA L4W-4T7
Applicant Contact KRIS SHAH
Correspondent
Baylis Medical Co., Inc.
5160 Explorer Dr., Unit 5
Mississauga,  CA L4W-4T7
Correspondent Contact KRIS SHAH
Regulation Number870.5175
Classification Product Code
DXF  
Date Received01/29/1999
Decision Date 02/01/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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