FDA.report

510(k) K971849

Device
CYTOLOGY BRUSH
Applicant
TEAM TECHNOLOGIES, INC.
510(k) number
K971849
Product code
HHT  
Decision
Substantially Equivalent (SESE)
Decision date
1997-07-24
Date received
1997-05-19
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
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
BOB WALTON
Address
5949 Commerce Blvd. Morristown TN US 37814 37814

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
00813360023035Cytology BrushTEAM TECHNOLOGIES, INC.2016-09-21
508133600230236.5" Cytology BrushTEAM TECHNOLOGIES, INC.2016-08-16
00813360023011Cytology BrushTEAM TECHNOLOGIES, INC.2016-08-15

Legacy Summary

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FDA Review

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