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 K022247
Device Name G-SPERM, MODEL 10032
Applicant
VITROLIFE SWEDEN AB
1800 MASSACHUSETTS AVENUE NW
WASHINGTON,  DC  20036 -1800
Applicant Contact GARY L YINGLING
Correspondent
VITROLIFE SWEDEN AB
1800 MASSACHUSETTS AVENUE NW
WASHINGTON,  DC  20036 -1800
Correspondent Contact GARY L YINGLING
Regulation Number884.6180
Classification Product Code
MQL  
Date Received07/12/2002
Decision Date 09/06/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-