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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name amniotome
510(k) Number K910518
Device Name GLOVE-N-GEL AMNIOTOMY KIT
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 Number884.4530
Classification Product Code
HGE  
Date Received02/06/1991
Decision Date 05/09/1991
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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