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 K921261
Device Name ELECTRIC POWERED BREAST PUMP
Applicant
SCHUCO, INC.
1419 EXPRESSWAY DRIVE NORTH
TOLEDO,  OH  43608
Applicant Contact RALPH SPANG
Correspondent
SCHUCO, INC.
1419 EXPRESSWAY DRIVE NORTH
TOLEDO,  OH  43608
Correspondent Contact RALPH SPANG
Regulation Number884.5160
Classification Product Code
HGX  
Date Received03/16/1992
Decision Date 11/09/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-