Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K133990
Device Classification Name
Perineometer
More FDA Info for this Device
510(K) Number
K133990
Device Name
Perineometer
Applicant
REMENDIUM LABS, LLC
340 EAST PARKER ROAD
BATON ROUGE, LA 70803 US
Other 510(k) Applications for this Company
Contact
YOLANDA LORIE
Other 510(k) Applications for this Contact
Regulation Number
884.1425
More FDA Info for this Regulation Number
Classification Product Code
HIR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/27/2013
Decision Date
10/09/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact