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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode, circular (spiral), scalp and applicator
510(k) Number K872057
Device Name FETAL SCALP ELECTRODE
Applicant
MEDICAL ACCESSORIES, INC.
92 YOUNGS RD.
TRENTON,  NJ  08619
Applicant Contact JANIS G ZIEDONIS
Correspondent
MEDICAL ACCESSORIES, INC.
92 YOUNGS RD.
TRENTON,  NJ  08619
Correspondent Contact JANIS G ZIEDONIS
Regulation Number884.2675
Classification Product Code
HGP  
Date Received05/28/1987
Decision Date 11/16/1987
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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