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 K962828
Device Name EVERT-IT
Applicant
GENESIS INDUSTRIES, INC.
601 PRO-JECT DR.
ELMWOOD,  WI  54740
Applicant Contact SYLVAN JOHNSON
Correspondent
GENESIS INDUSTRIES, INC.
601 PRO-JECT DR.
ELMWOOD,  WI  54740
Correspondent Contact SYLVAN JOHNSON
Regulation Number884.5150
Classification Product Code
HGY  
Date Received07/19/1996
Decision Date 02/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-