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 Apparatus, Suction, Operating-Room, Wall Vacuum Powered
510(k) Number K910377
Device Name COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM
Applicant
CooperSurgical, Inc.
C/O Charles I. Rose & Co, Inc.
1963 Rock St., Suite #17
Mountain View,  CA  94043
Applicant Contact CHARLES L ROSE
Correspondent
CooperSurgical, Inc.
C/O Charles I. Rose & Co, Inc.
1963 Rock St., Suite #17
Mountain View,  CA  94043
Correspondent Contact CHARLES L ROSE
Regulation Number880.6740
Classification Product Code
GCX  
Date Received01/29/1991
Decision Date 04/19/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-