Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K082086
Device Classification Name
Devices, Breath Trapping, Alcohol
More FDA Info for this Device
510(K) Number
K082086
Device Name
Devices, Breath Trapping, Alcohol
Applicant
THE ASHLEY COLLECTION, INC.
600 WEST 57TH ST.
NEW YORK, NY 10019 US
Other 510(k) Applications for this Company
Contact
ROBERT GOLDY
Other 510(k) Applications for this Contact
Regulation Number
862.3050
More FDA Info for this Regulation Number
Classification Product Code
DJZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/23/2008
Decision Date
12/19/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact