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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hysteroscope (And Accessories)
510(k) Number K982771
Device Name GYRUS HYSTEROSCOPIC RESECTOSCOPE
Applicant
Gyrus Medical , Ltd.
Fortran Rd., St. Mellons
Cardiff, Wales,  GB CF3 0LT
Applicant Contact DAVID KAY
Correspondent
Gyrus Medical , Ltd.
Fortran Rd., St. Mellons
Cardiff, Wales,  GB CF3 0LT
Correspondent Contact DAVID KAY
Regulation Number884.1690
Classification Product Code
HIH  
Date Received08/07/1998
Decision Date 01/21/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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