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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 K141057
Device Name DISPOSABLE CERVICAL BRUSH
Applicant
NINGBO HLS MEDICAL PRODUCTS CO., LTD
3500 SOUTH DUPONT HIGHWAY
DOVER,  DE  19901
Applicant Contact LEON LU
Correspondent
NINGBO HLS MEDICAL PRODUCTS CO., LTD
3500 SOUTH DUPONT HIGHWAY
DOVER,  DE  19901
Correspondent Contact LEON LU
Regulation Number884.4530
Classification Product Code
HHT  
Date Received04/24/2014
Decision Date 05/14/2015
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
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