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 K132668
Device Name IOB DISPOSABLE SPECULUM
Applicant
IOB MEDICAL INC
504E DIAMOND AVE.
SUITE F
GAITHERSBURG,  MD  20877
Applicant Contact JOE XIA
Correspondent
IOB MEDICAL INC
504E DIAMOND AVE.
SUITE F
GAITHERSBURG,  MD  20877
Correspondent Contact JOE XIA
Regulation Number884.4530
Classification Product Code
HIB  
Date Received08/27/2013
Decision Date 01/17/2014
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
-
-