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 Needle, Assisted Reproduction
510(k) Number K000628
Device Name WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733
Applicant
SIMS PORTEX LTD.
HYTHE
KENT,  GB CT21 6JL
Applicant Contact GILES BISHOP
Correspondent
SIMS PORTEX LTD.
HYTHE
KENT,  GB CT21 6JL
Correspondent Contact GILES BISHOP
Regulation Number884.6100
Classification Product Code
MQE  
Date Received02/24/2000
Decision Date 03/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-