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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
510(k) Number K202433
Device Name Aqueduct 200 Cervical Dilation Balloon Catheter
Applicant
Gtimd, LLC
6 Columbia Dr.
Amherst,  NH  03031
Applicant Contact Eran Levit
Correspondent
Gtimd, LLC
6 Columbia Dr.
Amherst,  NH  03031
Correspondent Contact Eran Levit
Regulation Number884.4260
Classification Product Code
PON  
Date Received08/25/2020
Decision Date 10/15/2021
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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