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 K990372
Device Name MODULAR INSTRUMENT SYSTEM FOR MINIMAL INVASIVE SURGERY
Applicant
DR. FRITZ GMBH
13311 BROOKS DRIVE, SUITE E
BALDWIN PARK,  CA  91706
Applicant Contact JAMES CHITTY
Correspondent
DR. FRITZ GMBH
13311 BROOKS DRIVE, SUITE E
BALDWIN PARK,  CA  91706
Correspondent Contact JAMES CHITTY
Regulation Number884.1720
Classification Product Code
HET  
Date Received02/08/1999
Decision Date 10/14/1999
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
-
-