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510(k) K160664

Aqueduct 100 Cervical Dilator by Gtimd, LLC — Product Code PON

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 1, 2016
Date Received: March 9, 2016
Clearance Type: Abbreviated
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Catheter, Balloon, Dilation Of Cervical Canal
Device Class: Class II
Regulation Number: 884.4260
Review Panel: OB
Submission Type

Mechanical dilation and softening of the cervix.