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 K021849
Device Name TAGG DISPOSABLE VAGINAL SPECULUM
Applicant
TAGG INDUSTRIES
23210 DEL LAGO
LAGUNA HILLS,  CA  92653
Applicant Contact TERRY L SHIRLEY
Correspondent
TAGG INDUSTRIES
23210 DEL LAGO
LAGUNA HILLS,  CA  92653
Correspondent Contact TERRY L SHIRLEY
Regulation Number884.4530
Classification Product Code
HIB  
Date Received06/05/2002
Decision Date 07/16/2002
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
-
-