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 Single-Use Reprocessed Ultrasonic Surgical Instruments
510(k) Number K050343
Device Name REPROCESSED HARMONIC SCALPELS
Applicant
Sterilmed, Inc.
11400 73rd Ave. N Suite 100
Maple Grove,  MN  55369
Applicant Contact BRUCE LESTER
Correspondent
Sterilmed, Inc.
11400 73rd Ave. N Suite 100
Maple Grove,  MN  55369
Correspondent Contact BRUCE LESTER
Classification Product Code
NLQ  
Date Received02/11/2005
Decision Date 04/12/2005
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-