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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 K954584
Device Name RACZ EPIDURAL CATHETER
Applicant
MEDIC EVALUATION DEVICES & INSTRUMENTS CORP.
6 DIVISION ST., P.O. BOX 1128
GLOVERSVILLE,  NY  12078
Applicant Contact DONALD R HENDERSON
Correspondent
MEDIC EVALUATION DEVICES & INSTRUMENTS CORP.
6 DIVISION ST., P.O. BOX 1128
GLOVERSVILLE,  NY  12078
Correspondent Contact DONALD R HENDERSON
Regulation Number868.5120
Classification Product Code
BSO  
Date Received10/02/1995
Decision Date 10/08/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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