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 Nebulizer (Direct Patient Interface)
510(k) Number K021443
Device Name 56 SERIES JET NEBULIZER
Applicant
PROJECT MARKETING
112 CAVISTON WAY
CARY,  NC  27560
Applicant Contact TERRY O'BRIEN
Correspondent
PROJECT MARKETING
112 CAVISTON WAY
CARY,  NC  27560
Correspondent Contact TERRY O'BRIEN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received05/06/2002
Decision Date 10/21/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-