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 Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K870819
Device Name BUBBLE TRAP CAT. NO. B-180
Applicant
American Omni Medical, Inc.
2930-G Grace Ln.
Costa Mesa,  CA  92626
Applicant Contact GEORGE G SIPOSS
Correspondent
American Omni Medical, Inc.
2930-G Grace Ln.
Costa Mesa,  CA  92626
Correspondent Contact GEORGE G SIPOSS
Regulation Number870.4210
Classification Product Code
DWF  
Date Received03/03/1987
Decision Date 06/08/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-