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 Pump, Portable, Aspiration (Manual Or Powered)
510(k) Number K851560
Device Name PORTASPIR II
Applicant
Roseburg SA
1054 31st St., NW
Suite 120 Canal Sq.
Washington,  DC  20007
Applicant Contact CHAMBORD
Correspondent
Roseburg SA
1054 31st St., NW
Suite 120 Canal Sq.
Washington,  DC  20007
Correspondent Contact CHAMBORD
Regulation Number878.4780
Classification Product Code
BTA  
Date Received04/16/1985
Decision Date 12/13/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-