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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
510(k) Number K262570
Device Name TZ Medical Birthing Balloon Kit
Applicant
TZ Medical
20497 SW Teton Ave.
Tualatin,  OR  97062
Applicant Contact John Lubisich
Correspondent
TZ Medical
20497 SW Teton Ave.
Tualatin,  OR  97062
Correspondent Contact John Lubisich
Regulation Number884.4260
Classification Product Code
PFJ  
Date Received07/24/2026
Decision Date 10/29/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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