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 Coagulator, Laparoscopic, Unipolar (And Accessories)
510(k) Number K904240
Device Name SINGLE USE LAPARSCOPIC ELECTRODE
Applicant
Aspen Labs
310 Broad St.
Utica,  NY  13501
Applicant Contact JANE JOHNSON
Correspondent
Aspen Labs
310 Broad St.
Utica,  NY  13501
Correspondent Contact JANE JOHNSON
Regulation Number884.4160
Classification Product Code
HFG  
Date Received09/13/1990
Decision Date 02/19/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-