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 K002912
Device Name VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073
Applicant
STERINC
3520 W. WARNER AVE.
SANTA ANTA,  CA  92704
Applicant Contact TODD ABRAHAM
Correspondent
STERINC
3520 W. WARNER AVE.
SANTA ANTA,  CA  92704
Correspondent Contact TODD ABRAHAM
Regulation Number884.4530
Classification Product Code
HIB  
Date Received09/18/2000
Decision Date 02/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-