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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Monitoring, Perinatal
510(k) Number K861189
Device Name TECNOL SECURE-ALL FETAL MONITOR STRAP
Applicant
Tecnol New Jersey Wound Care, Inc.
7450 Whitehall St.
Fort Worth,  TX  76012
Applicant Contact DAVID ARCHER
Correspondent
Tecnol New Jersey Wound Care, Inc.
7450 Whitehall St.
Fort Worth,  TX  76012
Correspondent Contact DAVID ARCHER
Regulation Number884.2740
Classification Product Code
HGM  
Date Received03/31/1986
Decision Date 04/08/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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