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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 K963801
Device Name PAP BRUSH
Applicant
Young OU Brush Co.
966-114 Kang Keun-Dong
Okpo-Meun, Dalsun-Kun
Kyong Buk,  KR
Applicant Contact STEVE KWAK
Correspondent
Young OU Brush Co.
966-114 Kang Keun-Dong
Okpo-Meun, Dalsun-Kun
Kyong Buk,  KR
Correspondent Contact STEVE KWAK
Regulation Number884.4530
Classification Product Code
HHT  
Date Received09/23/1996
Decision Date 04/09/1997
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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