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 trocar, sinus
510(k) Number K013987
Device Name REPROCESSED DISPOSABLE TROCARS
Applicant
ADVEN MEDICAL
1001 SLATON HWY.
LUBBOCK,  TX  79404
Applicant Contact MARK W ALDANA
Correspondent
ADVEN MEDICAL
1001 SLATON HWY.
LUBBOCK,  TX  79404
Correspondent Contact MARK W ALDANA
Regulation Number874.4420
Classification Product Code
KBG  
Subsequent Product Code
KCI  
Date Received12/04/2001
Decision Date 03/01/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-