Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K133712
Device Classification Name
Accessory, Assisted Reproduction
More FDA Info for this Device
510(K) Number
K133712
Device Name
Accessory, Assisted Reproduction
Applicant
UNISENSE FERTILITECH A/S
TUEAGER 1
AARHUS N DK-8200 DK
Other 510(k) Applications for this Company
Contact
Henrik Wahlgren
Other 510(k) Applications for this Contact
Regulation Number
884.6120
More FDA Info for this Regulation Number
Classification Product Code
MQG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/05/2013
Decision Date
08/08/2014
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