Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Spatula, Cervical, Cytological
510(k) Number K963685
Device Name EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER
Applicant
North Eos Industries, Inc.
54, Lane 1, Been St.
P.O. Box 22, Tung Shih
Taichung Hsien 423,  TW
Applicant Contact SARA CHEN
Correspondent
North Eos Industries, Inc.
54, Lane 1, Been St.
P.O. Box 22, Tung Shih
Taichung Hsien 423,  TW
Correspondent Contact SARA CHEN
Regulation Number884.4530
Classification Product Code
HHT  
Date Received09/03/1996
Decision Date 10/11/1996
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
Predetermined Change
Control Plan Authorized		 No
-
-