Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K133857
Device Classification Name
Speculum, Vaginal, Nonmetal
More FDA Info for this Device
510(K) Number
K133857
Device Name
Speculum, Vaginal, Nonmetal
Applicant
PROA MEDICAL, INC.
2512 Artesia Blvd Ste 305C
Redondo Beach, CA 90278 US
Other 510(k) Applications for this Company
Contact
VICTORIA NADERSHAHI
Other 510(k) Applications for this Contact
Regulation Number
884.4530
More FDA Info for this Regulation Number
Classification Product Code
HIB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/19/2013
Decision Date
04/28/2014
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