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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 K872908
Device Name ENDOMETRIAL SAMPLER
Applicant
ZINNANTI SURGICAL INSTRUMENTS, INC.
6311 DESOTO AVENUE, SUITE M
WOODLAND HILLS,  CA  91367
Applicant Contact THOMAS J ZINNANTI
Correspondent
ZINNANTI SURGICAL INSTRUMENTS, INC.
6311 DESOTO AVENUE, SUITE M
WOODLAND HILLS,  CA  91367
Correspondent Contact THOMAS J ZINNANTI
Regulation Number884.1175
Classification Product Code
HHK  
Date Received07/24/1987
Decision Date 10/20/1987
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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