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 Electrocautery, Gynecologic (And Accessories)
510(k) Number K913213
Device Name SINGLE USE LEE ELECTRODE
Applicant
ASPEN LABORATORIES, INC.
P.O. BOX 3936
ENGLEWOOD,  CO  80155 -3936
Applicant Contact JANE JOHNSON
Correspondent
ASPEN LABORATORIES, INC.
P.O. BOX 3936
ENGLEWOOD,  CO  80155 -3936
Correspondent Contact JANE JOHNSON
Regulation Number884.4120
Classification Product Code
HGI  
Date Received07/19/1991
Decision Date 02/13/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-