Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K092398
Device Classification Name
Labware, Assisted Reproduction
More FDA Info for this Device
510(K) Number
K092398
Device Name
Labware, Assisted Reproduction
Applicant
CRYO BIO SYSTEM
26552 TAMPICO PLACE
MISSION VIEJO, CA 92691 US
Other 510(k) Applications for this Company
Contact
DAVE BALDING
Other 510(k) Applications for this Contact
Regulation Number
884.6160
More FDA Info for this Regulation Number
Classification Product Code
MQK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/06/2009
Decision Date
10/06/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact