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 Colposcope (And Colpomicroscope)
510(k) Number K902313
Device Name LM-1Z ZOOM SCOPE
Applicant
LEISEGANG MEDICAL, INC.
6401 CONGRESS AVE.
BOCA RATON,  FL  33487 -2883
Applicant Contact DOUGLAS KWART
Correspondent
LEISEGANG MEDICAL, INC.
6401 CONGRESS AVE.
BOCA RATON,  FL  33487 -2883
Correspondent Contact DOUGLAS KWART
Regulation Number884.1630
Classification Product Code
HEX  
Date Received05/23/1990
Decision Date 09/04/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-