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510(k) K963801

Device
PAP BRUSH
Applicant
YOUNG OU BRUSH CO.
510(k) number
K963801
Product code
HHT  
Decision
Substantially Equivalent (SESE)
Decision date
1997-04-09
Date received
1996-09-23
Regulation
884.4530
Classification name
Spatula, Cervical, Cytological
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
STEVE KWAK
Address
966-114 Kang Keun-Dong Okpo-Meun, Dalsun-Kun Kyong Buk KR

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HHT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K182049exCellerator Cervical Collection DeviceExcell Company, LLC2019-04-25
K153128Kolplast Cervical Sample Collection KitKolplast CI SA2017-01-13
K141057DISPOSABLE CERVICAL BRUSHNingbo Hls Medical Products Co., Ltd.2015-05-14
K111681HISTOBRUSHPuritan Medical Products Company, LLC2012-01-19
K083012PAPCONEOtto Bock Pur Life Science GmbH2009-04-09
K081522BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGYBio Nuclear Diagnostics, Inc.2008-12-05
K072381SOFTPAP CERVICAL CELL COLLECTORCytocore, Inc.2008-01-30
K062433DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEMDiamics, Inc.2007-03-16
K043369CERVEX-BRUSH COMBIRovers Medical Devices B.V.2005-02-02
K042527SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107Medical Action Industries, Inc.2004-11-08
K041018DRG SOFTRELEASEDoctor'S Research Group, Inc.2004-10-18
K013258INPATH E2 COLLECTORMolecular Diagnostics2002-05-31
K002520ROVERS SPATULARovers Medical Devices B.V.2000-11-13
K001119ROVERS ENDOCERVEX-BRUSHRovers Medical Devices B.V.2000-05-19
K991593ORIBRUSH - STANDARD - B002Orifice Medical AB1999-06-29

Legacy Summary#

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FDA Review#

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