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, Non-Powered
510(k) Number K952034
Device Name MEDELA'S FOOT PUMP
Applicant
Medela, Inc.
4610 Prime Pkwy.
P.O. Box 660
Mchenry,  IL  60050
Applicant Contact STEPHEN D SMITH
Correspondent
Medela, Inc.
4610 Prime Pkwy.
P.O. Box 660
Mchenry,  IL  60050
Correspondent Contact STEPHEN D SMITH
Regulation Number884.5150
Classification Product Code
HGY  
Date Received05/01/1995
Decision Date 09/12/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-