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 catheter, assisted reproduction
510(k) Number K000656
Device Name EMBRYON GIFT TRANSFER CATHETERS/SETS
Applicant
ROCKET MEDICAL PLC
WARE INDUSTRIAL ESTATE
WASHINGTON, TYNE & WEAR,  GB NE37 1NE
Applicant Contact LES TODD
Correspondent
ROCKET MEDICAL PLC
WARE INDUSTRIAL ESTATE
WASHINGTON, TYNE & WEAR,  GB NE37 1NE
Correspondent Contact LES TODD
Regulation Number884.6110
Classification Product Code
MQF  
Date Received02/28/2000
Decision Date 03/09/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-