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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 K850505
Device Name DESERET EPIDURAL CATHETER W/TOUGHY-BORST ADAPTER
Applicant
Parke-Davis Co.
870 Parkdale Rd.
Rochester,  MI  48307
Applicant Contact CLEARY
Correspondent
Parke-Davis Co.
870 Parkdale Rd.
Rochester,  MI  48307
Correspondent Contact CLEARY
Regulation Number868.5120
Classification Product Code
BSO  
Date Received02/08/1985
Decision Date 03/11/1985
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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