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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 K802065
Device Name CONTINUOUS EPIDURAL ANESTHESIA TRAY/DRUG
Applicant
PORTEX, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
PORTEX, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5120
Classification Product Code
BSO  
Date Received08/27/1980
Decision Date 09/09/1980
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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