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 K021237
Device Name COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS
Applicant
COOPERSURGICAL, INC.
KAISERSTR.9
TUNINGEN,  DE D-78609
Applicant Contact HAIKO BELL
Correspondent
COOPERSURGICAL, INC.
KAISERSTR.9
TUNINGEN,  DE D-78609
Correspondent Contact HAIKO BELL
Regulation Number884.1720
Classification Product Code
HET  
Date Received04/18/2002
Decision Date 04/10/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-