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 Valve, Non-Rebreathing
510(k) Number K091538
Device Name PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100
Applicant
Wet Nose Technologies, LLC
3750 2nd Ave.
Los Angeles,  CA  90018
Applicant Contact JIM BARLEY
Correspondent
Wet Nose Technologies, LLC
3750 2nd Ave.
Los Angeles,  CA  90018
Correspondent Contact JIM BARLEY
Regulation Number868.5870
Classification Product Code
CBP  
Date Received05/26/2009
Decision Date 03/25/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-