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 K051227
Device Name RENU MEDICAL REPROCESSED ALP 1 CALF GARMENT, MODEL ALP1
Applicant
RENU MEDICAL, INC.
9800 EVERGREEN WAY
EVERETT,  WA  98204
Applicant Contact GEORGE BIGGINS
Correspondent
RENU MEDICAL, INC.
9800 EVERGREEN WAY
EVERETT,  WA  98204
Correspondent Contact GEORGE BIGGINS
Regulation Number870.5800
Classification Product Code
JOW  
Date Received05/12/2005
Decision Date 04/07/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-