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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Conduction, Anesthetic
510(k) Number K850009
Device Name EVANS, VAS-CATH EPIDURAL NEEDLE & CATHETER
Applicant
Vas-Cath of Canada , Ltd.
2380 Tedlo St. Mississauga
Ontario, L5a 3v3,  CA
Applicant Contact KAMAL KALWANI
Correspondent
Vas-Cath of Canada , Ltd.
2380 Tedlo St. Mississauga
Ontario, L5a 3v3,  CA
Correspondent Contact KAMAL KALWANI
Regulation Number868.5120
Classification Product Code
BSO  
Date Received01/02/1985
Decision Date 05/13/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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