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 Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K982130
Device Name RETURN ELECTRODE CLAMP SHELL CORD MODEL RC 201
Applicant
New Deantronics, Ltd.
4655 Kirkwood Court
Boulder,  CO  80301
Applicant Contact LEWIS WARD
Correspondent
New Deantronics, Ltd.
4655 Kirkwood Court
Boulder,  CO  80301
Correspondent Contact LEWIS WARD
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/17/1998
Decision Date 08/07/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-