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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 K952652
Device Name MEDSCAND ENDORETTE ENDOMETRIAL SAMPLER
Applicant
MEDSCAND (USA), INC.
P.O. BOX 7733
HOLLYWOOD,  FL  33081
Applicant Contact TENNY P TSE
Correspondent
MEDSCAND (USA), INC.
P.O. BOX 7733
HOLLYWOOD,  FL  33081
Correspondent Contact TENNY P TSE
Regulation Number884.1175
Classification Product Code
HHK  
Date Received06/09/1995
Decision Date 09/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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