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 K040817
Device Name POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM
Applicant
ADVANCED UROLOGICAL DEVELOPMENTS
485 DARTMOUTH AVENUE
SAN CARLOS,  CA  94070
Applicant Contact GERMAN BORODULIN
Correspondent
ADVANCED UROLOGICAL DEVELOPMENTS
485 DARTMOUTH AVENUE
SAN CARLOS,  CA  94070
Correspondent Contact GERMAN BORODULIN
Regulation Number884.4530
Classification Product Code
HIB  
Date Received03/30/2004
Decision Date 06/22/2004
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
-
-