Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K152159
Device Classification Name
Device, Anti-Snoring
More FDA Info for this Device
510(K) Number
K152159
Device Name
Device, Anti-Snoring
Applicant
OravanOSA, LLC
769 Northfield Avenue, Suite 160
West Orange, NJ 07052 US
Other 510(k) Applications for this Company
Contact
Deborah Stein
Other 510(k) Applications for this Contact
Regulation Number
872.5570
More FDA Info for this Regulation Number
Classification Product Code
LRK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/03/2015
Decision Date
10/29/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
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