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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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