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 Filter, Bacterial, Breathing-Circuit
510(k) Number K033008
Device Name AIR SAFETY HEPA AND NON-HEPA FILTERS
Applicant
Air Safety, Ltd.
6329 W. Waterview Ct.
Mccordsville,  IN  46055
Applicant Contact PAUL DRYDEN
Correspondent
Air Safety, Ltd.
6329 W. Waterview Ct.
Mccordsville,  IN  46055
Correspondent Contact PAUL DRYDEN
Regulation Number868.5260
Classification Product Code
CAH  
Date Received09/26/2003
Decision Date 05/13/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-