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 Counter, Sponge, Surgical
510(k) Number K062642
Device Name RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A
Applicant
Rf Surgical Systems, Inc.
2700 Richards Rd. Suite 204
Bellevue,  WA  98005
Applicant Contact KEVIN COSENS
Correspondent
Rf Surgical Systems, Inc.
2700 Richards Rd. Suite 204
Bellevue,  WA  98005
Correspondent Contact KEVIN COSENS
Regulation Number880.2740
Classification Product Code
LWH  
Date Received09/06/2006
Decision Date 11/02/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-