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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Speculum, Vaginal, Nonmetal
510(k) Number K252208
Device Name JFord Speculum Sleeve™
Applicant
Ford Medtech, LLC
251 Post Ave., 2nd Floor
Westbury,  NY  11590
Applicant Contact Jacqueline Ford
Correspondent
The Jans Group, LLC
4417 New Hope Springs Dr.
Hillsborough,  NC  27278
Correspondent Contact Michele Jans
Regulation Number884.4530
Classification Product Code
HIB  
Date Received07/15/2025
Decision Date 03/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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