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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Remover, Intrauterine Device, Contraceptive, Hook-Type
510(k) Number K811761
Device Name THE EMMETT IUD THREAD RETRIEVER
Applicant
PROTO-MED, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PROTO-MED, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.4530
Classification Product Code
HHF  
Date Received06/22/1981
Decision Date 09/21/1981
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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