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, Exhaust, Surgical
510(k) Number K844087
Device Name XANAR MODEL XSE-300 SMOKE EVACULATER
Applicant
Xanar, Inc.
2868 Janitell Rd.
Colorado Springs,  CO  80906
Applicant Contact DALTON
Correspondent
Xanar, Inc.
2868 Janitell Rd.
Colorado Springs,  CO  80906
Correspondent Contact DALTON
Regulation Number878.5070
Classification Product Code
FYD  
Date Received10/22/1984
Decision Date 02/27/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-