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 K864851
Device Name MODEL FORCE 100 BIPOLAR ELECTROSURGICAL GENERATOR
Applicant
Valleylab, Inc.
5920 Longbow Dr.
Boulder,  CO  80301
Applicant Contact PEGGY WALLINE
Correspondent
Valleylab, Inc.
5920 Longbow Dr.
Boulder,  CO  80301
Correspondent Contact PEGGY WALLINE
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/10/1986
Decision Date 01/08/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-