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 Dressing, Wound, Drug
510(k) Number K070685
Device Name KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662
Applicant
Tyco Healthcare
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact PAUL W EVANS
Correspondent
Tyco Healthcare
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact PAUL W EVANS
Classification Product Code
FRO  
Date Received03/12/2007
Decision Date 09/14/2007
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
-
-