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 media, reproductive
510(k) Number K022335
Device Name ALLGRAD AND ALLGRAD100
Applicant
<GENX> INTL., INC.
393 SOUNDVIEW RD.
GUILFORD,  CT  06443
Applicant Contact MICHAEL D CECCHI
Correspondent
INTL., INC.
393 SOUNDVIEW RD.
GUILFORD,  CT  06443
Correspondent Contact MICHAEL D CECCHI
Regulation Number884.6180
Classification Product Code
MQL  
Date Received07/18/2002
Decision Date 08/23/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-