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 K003540
Device Name (DISPOSABLE) VAGINAL SPECULUM
Applicant
FEMINICA, INC.
3216 MONSABRE
MONTREAL, QUEBEC,  CA H1N 2L5
Applicant Contact DENIS H DUBOIS
Correspondent
FEMINICA, INC.
3216 MONSABRE
MONTREAL, QUEBEC,  CA H1N 2L5
Correspondent Contact DENIS H DUBOIS
Regulation Number884.4530
Classification Product Code
HIB  
Date Received11/16/2000
Decision Date 02/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-