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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Obstetric (And Accessories)
510(k) Number K864194
Device Name PALMER OBSTETRIC BRACE
Applicant
Ad-Tech Medical Instrument Corp
1901 William St.,
Racine,  WI  53404
Applicant Contact DAVID A PUTZ
Correspondent
Ad-Tech Medical Instrument Corp
1901 William St.,
Racine,  WI  53404
Correspondent Contact DAVID A PUTZ
Regulation Number884.4900
Classification Product Code
KNC  
Date Received10/27/1986
Decision Date 01/14/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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