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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 K820115
Device Name EMMETT IUD THREAD RETREIVER
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 Received01/18/1982
Decision Date 02/05/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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