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 pump, breast, powered
510(k) Number K052909
Device Name EVENFLO ELAN BREAST PUMP
Applicant
EVENFLO COMPANY, INC.
707 CROSSROADS COURT
VANDALIA,  OH  45377
Applicant Contact THOMAS A SPARNO
Correspondent
UNDERWRITERS LABORATORIES, INC.
1655 SCOTT BLVD.
SANTA CLARA,  CA  95050
Correspondent Contact MORTEN SIMON CHRISTENESEN
Regulation Number884.5160
Classification Product Code
HGX  
Date Received10/17/2005
Decision Date 11/01/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
-
-