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 Microtools, Assisted Reproduction (Pipettes)
510(k) Number K991261
Device Name ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, ASSISTED HATCHING/ZONA DRILLING MICROPIPET
Applicant
Research Instruments , Ltd.
Kernick Rd.
Penryn, Corwall,  GB TR 10 9DQ
Applicant Contact DAVID C LANSDOWNE
Correspondent
Research Instruments , Ltd.
Kernick Rd.
Penryn, Corwall,  GB TR 10 9DQ
Correspondent Contact DAVID C LANSDOWNE
Regulation Number884.6130
Classification Product Code
MQH  
Date Received04/13/1999
Decision Date 08/05/1999
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
Predetermined Change
Control Plan Authorized		 No
-
-