Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K093901
Device Classification Name
Mask, Surgical
More FDA Info for this Device
510(K) Number
K093901
Device Name
Mask, Surgical
Applicant
EPARD PROTECTIVE PRODUCTS, LTD
15637 FOX COVE CIRCLE
MOSELEY, VA 23120 US
Other 510(k) Applications for this Company
Contact
DARREN REEVES
Other 510(k) Applications for this Contact
Regulation Number
878.4040
More FDA Info for this Regulation Number
Classification Product Code
FXX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/22/2009
Decision Date
09/10/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact