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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 K831568
Device Name RELIANCE TEMPO OPHTH. INSTR STAND
Applicant
F. & F. Koenigkramer
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
F. & F. Koenigkramer
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number884.4530
Classification Product Code
HHF  
Date Received05/16/1983
Decision Date 06/30/1983
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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