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 K102480
Device Name INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HA
Applicant
Jieying Laboratory, Inc.
9722 Ave. Sausalito
Irvine,  CA  92606
Applicant Contact GRACE HOLLAND
Correspondent
Jieying Laboratory, Inc.
9722 Ave. Sausalito
Irvine,  CA  92606
Correspondent Contact GRACE HOLLAND
Regulation Number884.6130
Classification Product Code
MQH  
Date Received08/30/2010
Decision Date 04/19/2011
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
Predetermined Change
Control Plan Authorized		 No
-
-