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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 K822436
Device Name DNA MEDICAL DURACATH
Applicant
Moorehead Hospital Products, Inc.
NC 
Correspondent
Moorehead Hospital Products, Inc.
NC 
Regulation Number868.5120
Classification Product Code
BSO  
Date Received08/13/1982
Decision Date 10/22/1982
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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