Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K093648
Device Classification Name
Pump, Breast, Powered
More FDA Info for this Device
510(K) Number
K093648
Device Name
Pump, Breast, Powered
Applicant
SIMPLISSE INC.
1340 WEST PENNSYLVANIA AVE
SAN DIEGO, CA 92103 US
Other 510(k) Applications for this Company
Contact
Glen Feye
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
11/25/2009
Decision Date
07/14/2010
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