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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 Ave., Suite M
Woodland Hills,  CA  91367
Applicant Contact THOMAS J ZINNANTI
Correspondent
Zinnanti Surgical Instruments, Inc.
6311 Desoto Ave., 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
Predetermined Change
Control Plan Authorized		 No
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