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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colposcope (And Colpomicroscope)
510(k) Number K233043
Device Name Smart Scope® CX
Applicant
Periwinkle Technologies Pvt., Ltd.
B1, Samrat Ashok Chs, S. # 88/2, Veerbhadra Nagar, Baner,
Pune,  IN 411045
Applicant Contact Veena Moktali
Correspondent
IZiel Healthcare
Pentagon P1, Office # 601 And 604, Magarpatta City
Pune,  IN 411028
Correspondent Contact Ankur Naik
Regulation Number884.1630
Classification Product Code
HEX  
Date Received09/25/2023
Decision Date 06/14/2024
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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