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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Laparoscopic
510(k) Number K232464
Device Name VereSee Optical Veres Needle System
Applicant
Freyja Healthcare, LLC
488 Pleasant St.
North Andover,  MA  01845
Applicant Contact Ronald Adams
Correspondent
Brauer Device Consultants, LLC
7 Trl. House Ct.
Rockville,  MD  20850
Correspondent Contact Christine Brauer, PhD
Regulation Number884.1730
Classification Product Code
HIF  
Date Received08/15/2023
Decision Date 05/02/2024
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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