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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cap, Cervical
510(k) Number K881414
Device Name CERVICATH
Applicant
Epcom Medical Systems, Inc.
302 Lindbergh Ave.
Livermore,  CA  94550
Applicant Contact PAUL ULBRICH
Correspondent
Epcom Medical Systems, Inc.
302 Lindbergh Ave.
Livermore,  CA  94550
Correspondent Contact PAUL ULBRICH
Regulation Number884.5250
Classification Product Code
HDR  
Date Received04/04/1988
Decision Date 06/14/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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