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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name curette, suction, endometrial (and accessories)
510(k) Number K803210
Device Name MENSTRUAL ASPIRATION KITS
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 Number884.1175
Classification Product Code
HHK  
Date Received12/18/1980
Decision Date 01/28/1981
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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