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 K993527
Device Name LOOP ELECTRODE, BALL ELECTRODE
Applicant
PALM MEDICAL USA, INC.
6322 N.W. 18TH DR., SUITE 170
GAINESVILLE,  FL  32653
Applicant Contact MARK J KAHN
Correspondent
PALM MEDICAL USA, INC.
6322 N.W. 18TH DR., SUITE 170
GAINESVILLE,  FL  32653
Correspondent Contact MARK J KAHN
Regulation Number884.4120
Classification Product Code
HGI  
Date Received10/18/1999
Decision Date 07/06/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-