Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K080752
Device Classification Name
Kit, Conception-Assist, Home Use
More FDA Info for this Device
510(K) Number
K080752
Device Name
Kit, Conception-Assist, Home Use
Applicant
CONCEIVEX INC.
2600 MULLINIX MILL ROAD
MT. AIRY, MD 21771-0031 US
Other 510(k) Applications for this Company
Contact
BLIX WINSTON
Other 510(k) Applications for this Contact
Regulation Number
884.5250
More FDA Info for this Regulation Number
Classification Product Code
OBB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/17/2008
Decision Date
05/14/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact