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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 K884969
Device Name BIO-MATE(TM) EPIDURAL CATHETER
Applicant
MEDEVICE, INC.
5080 TIMBERLEA BLVD.
UNIT 11, MISSISSAUGA, ONTARIO
CANADA L4W 4M2,  CA
Applicant Contact RALPH D MANDELL
Correspondent
MEDEVICE, INC.
5080 TIMBERLEA BLVD.
UNIT 11, MISSISSAUGA, ONTARIO
CANADA L4W 4M2,  CA
Correspondent Contact RALPH D MANDELL
Regulation Number868.5120
Classification Product Code
BSO  
Date Received11/30/1988
Decision Date 06/23/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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