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 K890431
Device Name PLEUR-EVAC(R) A-8000--ADULT/PEDIATRIC CHEST DRAIN
Applicant
Deknatel, Inc.
Kilometer 9 Carretera
San Jose-Heredia,  CR
Applicant Contact AMY PETERSON
Correspondent
Deknatel, Inc.
Kilometer 9 Carretera
San Jose-Heredia,  CR
Correspondent Contact AMY PETERSON
Regulation Number880.6740
Classification Product Code
GCX  
Date Received01/27/1989
Decision Date 04/04/1989
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
-
-