Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K212302
Device Classification Name
Mask, Surgical
More FDA Info for this Device
510(K) Number
K212302
Device Name
Mask, Surgical
Applicant
Baylab USA, LLC
2230 Lyndon B Johnson Freeway, Suite 100
Dallas, TX 75234 US
Other 510(k) Applications for this Company
Contact
Ashley Park
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
07/23/2021
Decision Date
12/07/2021
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