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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 K844183
Device Name PALMER OBSTETIC BRACE
Applicant
Mic Medical Corp.
2775 N. 32nd St.
Milwaukee,  WI  53210
Applicant Contact MICHAEL KRYSHAK
Correspondent
Mic Medical Corp.
2775 N. 32nd St.
Milwaukee,  WI  53210
Correspondent Contact MICHAEL KRYSHAK
Regulation Number884.4900
Classification Product Code
KNC  
Date Received10/26/1984
Decision Date 02/04/1985
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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