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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name insufflator, carbon-dioxide, uterotubal (and accessories)
510(k) Number K873515
Device Name UTERINE INJECTOR 2MM
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 Number884.1300
Classification Product Code
HES  
Date Received08/31/1987
Decision Date 09/29/1987
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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