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 K091648
Device Name NURSE'S ASSISTANT O.R. CONTROL SYSTEM ,1.8
Applicant
Conmed Integrated Systems (Cmis)
1815 NW 169th Pl.
Suite 4020
Beaverton,  OR  97006
Applicant Contact C. JEFF LIPPS
Correspondent
Conmed Integrated Systems (Cmis)
1815 NW 169th Pl.
Suite 4020
Beaverton,  OR  97006
Correspondent Contact C. JEFF LIPPS
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
OCS  
Date Received06/09/2009
Decision Date 08/05/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-