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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, anesthesia, obstetric
510(k) Number K862358
Device Name EPICATH
Applicant
HDC CORP.
2551 CASEY AVE.
MOUNTAIN VIEW,  CA  94043
Applicant Contact WILLIAM J SCHRODER
Correspondent
HDC CORP.
2551 CASEY AVE.
MOUNTAIN VIEW,  CA  94043
Correspondent Contact WILLIAM J SCHRODER
Regulation Number884.5100
Classification Product Code
KNE  
Date Received06/23/1986
Decision Date 07/07/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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