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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 K202427
Device Name Aqueduct 100 Plus Cervical Dilation Balloon Catheter
Applicant
GTIMD LLC
6 Columbia Drive
Amherst,  NH  03031
Applicant Contact Eran Levit
Correspondent
GTIMD LLC
6 Columbia Drive
Amherst,  NH  03031
Correspondent Contact Eran Levit
Regulation Number884.4260
Classification Product Code
PON  
Date Received08/25/2020
Decision Date 11/06/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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