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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 K842295
Device Name INTRAUTERINE DEVICE REMOVER
Applicant
Premier Dental Products Co.
P.O. Box 111
Norristown,  PA  19404
Applicant Contact WILLIAM J FREZEL
Correspondent
Premier Dental Products Co.
P.O. Box 111
Norristown,  PA  19404
Correspondent Contact WILLIAM J FREZEL
Regulation Number884.4530
Classification Product Code
HHF  
Date Received06/11/1984
Decision Date 10/12/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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