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 sleeve, limb, compressible
510(k) Number K003284
Device Name PHLEBOPUMP, MODEL 1000
Applicant
PREVENT PRODUCTS, INC.
1167 OTTAWA AVE.
W ST PAUL,  MN  55118
Applicant Contact CAROL A GARCIA
Correspondent
PREVENT PRODUCTS, INC.
1167 OTTAWA AVE.
W ST PAUL,  MN  55118
Correspondent Contact CAROL A GARCIA
Regulation Number870.5800
Classification Product Code
JOW  
Date Received10/19/2000
Decision Date 01/17/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-