Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K101000
Device Classification Name
Mask, Surgical
More FDA Info for this Device
510(K) Number
K101000
Device Name
Mask, Surgical
Applicant
WELLMIEN (SUZHOU) IMPORT & EXPORT TRADING CO., LTD
PENNINGTON, NJ 08534 US
Other 510(k) Applications for this Company
Contact
CHENGYU SHEN
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
04/12/2010
Decision Date
08/09/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact