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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Manual, General Obstetric-Gynecologic
510(k) Number K921732
Device Name MINOR LAP SET
Applicant
Medikmark, Inc.
333 W. Wacker Dr.
Suite 2600
Chicago,  IL  60606
Applicant Contact RICHARD O WOOD
Correspondent
Medikmark, Inc.
333 W. Wacker Dr.
Suite 2600
Chicago,  IL  60606
Correspondent Contact RICHARD O WOOD
Regulation Number884.4520
Classification Product Code
KOH  
Date Received04/10/1992
Decision Date 06/15/1994
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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