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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spatula, Cervical, Cytological
510(k) Number K182049
Device Name exCellerator Cervical Collection Device
Applicant
Excell Company, LLC
1540 W. Main St.
Carmel,  IN  46032
Applicant Contact Jim Snyder
Correspondent
Excell Company, LLC
1540 W. Main St.
Carmel,  IN  46032
Correspondent Contact Jim Snyder
Regulation Number884.4530
Classification Product Code
HHT  
Date Received07/31/2018
Decision Date 04/25/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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