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 pump, portable, aspiration (manual or powered)
510(k) Number K980454
Device Name LYSONIX ASPIRATION PUMP
Applicant
LYSONIX, INC.
1170 MARK AVE.
CARPINTERIA,  CA  93013
Applicant Contact RONALD F LAGERQUIST
Correspondent
LYSONIX, INC.
1170 MARK AVE.
CARPINTERIA,  CA  93013
Correspondent Contact RONALD F LAGERQUIST
Regulation Number878.4780
Classification Product Code
BTA  
Subsequent Product Code
JCX  
Date Received02/05/1998
Decision Date 03/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-