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, General & Plastic Surgery
510(k) Number K041967
Device Name GENICON SUCTION IRRIGATION SYSTEM
Applicant
GENICON
427 LAKE HOWELL
MAITLAND,  FL  32751
Applicant Contact GARY HABERLAND
Correspondent
GENICON
427 LAKE HOWELL
MAITLAND,  FL  32751
Correspondent Contact GARY HABERLAND
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received07/21/2004
Decision Date 11/12/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-