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 Drape, Surgical
510(k) Number K043015
Device Name 3L SURGICAL DRAPES
Applicant
3L MEDICAL PRODUCTS CO., LTD.
1800 CENTURY PARK EAST
SUITE 600
CENTURY CITY,  CA  90067
Applicant Contact GEORGE SU
Correspondent
3L MEDICAL PRODUCTS CO., LTD.
1800 CENTURY PARK EAST
SUITE 600
CENTURY CITY,  CA  90067
Correspondent Contact GEORGE SU
Regulation Number878.4370
Classification Product Code
KKX  
Date Received11/02/2004
Decision Date 08/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-