Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Devices, Breath Trapping, Alcohol
510(k) Number K082086
Device Name KEY RING ALCOHOL BREATHALYZER
Applicant
The Ashley Collection, Inc.
600 W. 57th St.
New York,  NY  10019
Applicant Contact ROBERT GOLDY
Correspondent
The Ashley Collection, Inc.
600 W. 57th St.
New York,  NY  10019
Correspondent Contact ROBERT GOLDY
Regulation Number862.3050
Classification Product Code
DJZ  
Date Received07/23/2008
Decision Date 12/19/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-