Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K102909
Device Classification Name
Mouthguard, Prescription
More FDA Info for this Device
510(K) Number
K102909
Device Name
Mouthguard, Prescription
Applicant
SOMNOMED INC
7460 WARREN PARKWAY
SUITE 190
FRISCO, TX 75034 US
Other 510(k) Applications for this Company
Contact
BRADLEY SOUTHWORTH
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
MQC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/01/2010
Decision Date
12/13/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact