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 Laparoscope, Gynecologic (And Accessories)
510(k) Number K963076
Device Name LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY
Applicant
LOUISVILLE LABORATORIES, INC.
2400 CRITTENDEN DR.
LOUISVILLE,  KY  40217 -1865
Applicant Contact DAVID PHELPS
Correspondent
LOUISVILLE LABORATORIES, INC.
2400 CRITTENDEN DR.
LOUISVILLE,  KY  40217 -1865
Correspondent Contact DAVID PHELPS
Regulation Number884.1720
Classification Product Code
HET  
Subsequent Product Codes
EZL   JDR  
Date Received08/07/1996
Decision Date 04/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-