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 labware, assisted reproduction
510(k) Number K092398
Device Name HSV STRAW
Applicant
CRYO BIO SYSTEM
26552 TAMPICO PLACE
MISSION VIEJO,  CA  92691
Applicant Contact DAVE BALDING
Correspondent
CRYO BIO SYSTEM
26552 TAMPICO PLACE
MISSION VIEJO,  CA  92691
Correspondent Contact DAVE BALDING
Regulation Number884.6160
Classification Product Code
MQK  
Date Received08/06/2009
Decision Date 10/06/2010
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
-
-