Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K082307
Device Classification Name
Pump, Breast, Powered
More FDA Info for this Device
510(K) Number
K082307
Device Name
Pump, Breast, Powered
Applicant
EVENFLO COMPANY, INC.
225 BYERS RD.
MIAMISBURG, OH 45342 US
Other 510(k) Applications for this Company
Contact
AMY NEFF
Other 510(k) Applications for this Contact
Regulation Number
884.5160
More FDA Info for this Regulation Number
Classification Product Code
HGX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/13/2008
Decision Date
09/11/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact