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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 K863610
Device Name THE OB-GYN CONCEPTS VAGINAL ASPIRATOR
Applicant
Ob/Gyn Concepts, Ltd.
613 Dock Dr.
Barrington,  IL  60010
Applicant Contact CHARLES B ROOT
Correspondent
Ob/Gyn Concepts, Ltd.
613 Dock Dr.
Barrington,  IL  60010
Correspondent Contact CHARLES B ROOT
Regulation Number884.4520
Classification Product Code
KOH  
Date Received09/16/1986
Decision Date 01/07/1987
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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