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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Cervical, Fixed Size
510(k) Number K811568
Device Name CERVICAL DILATOR
Applicant
GYNEMETRICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
GYNEMETRICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.4530
Classification Product Code
HDQ  
Date Received06/04/1981
Decision Date 07/16/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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