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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Abortion, Vacuum
510(k) Number K841631
Device Name MODEL 3014 SUCTION UNIT
Applicant
FORMA SCIENTIFIC, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
FORMA SCIENTIFIC, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.5070
Classification Product Code
HHI  
Date Received04/20/1984
Decision Date 07/03/1984
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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