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 K933961
Device Name MARSAM MODEL 2000 NEBULIZER
Applicant
MARSAM PHARMACEUTICALS, INC.
OLNEY AVE. P.O. BOX 1022
CHERRY HILL,  NJ  08034
Applicant Contact JUDITH U ARNOFF
Correspondent
MARSAM PHARMACEUTICALS, INC.
OLNEY AVE. P.O. BOX 1022
CHERRY HILL,  NJ  08034
Correspondent Contact JUDITH U ARNOFF
Regulation Number868.5630
Classification Product Code
CAF  
Date Received08/13/1993
Decision Date 09/19/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-