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 Speculum, Vaginal, Nonmetal
510(k) Number K030761
Device Name KAISHOU VAGINAL SPECULUM
Applicant
JIANGSU KAISHOU MEDICAL APPARATUS CO., LTD
600 LIU ZHOU ROAD
8 BUILDING, 503 ROOM
SHANGHAI,  CN 200233
Applicant Contact GONG BO
Correspondent
JIANGSU KAISHOU MEDICAL APPARATUS CO., LTD
600 LIU ZHOU ROAD
8 BUILDING, 503 ROOM
SHANGHAI,  CN 200233
Correspondent Contact GONG BO
Regulation Number884.4530
Classification Product Code
HIB  
Date Received03/11/2003
Decision Date 06/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-