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 K873930
Device Name AEROSOL DELIVERY SYSTEM (AERO-TECH II)
Applicant
Cadema Medical Products, Inc.
P.O. Box 250
Middletown,  NY  10940
Applicant Contact KATHLEEN D BORDONI
Correspondent
Cadema Medical Products, Inc.
P.O. Box 250
Middletown,  NY  10940
Correspondent Contact KATHLEEN D BORDONI
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/25/1987
Decision Date 12/07/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-