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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Curette, Suction, Endometrial (And Accessories)
510(k) Number K001555
Device Name SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26
Applicant
SIMS PORTEX LTD.
HYTHE
HYTHE, KENT,  GB CT 21 6JL
Applicant Contact STEVEN M OGILVIE
Correspondent
SIMS PORTEX LTD.
HYTHE
HYTHE, KENT,  GB CT 21 6JL
Correspondent Contact STEVEN M OGILVIE
Regulation Number884.1175
Classification Product Code
HHK  
Date Received05/18/2000
Decision Date 08/02/2000
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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