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 Filter, Conduction, Anesthetic
510(k) Number K960928
Device Name SYRINGEFILTER
Applicant
Arbor Technologies, Inc.
401 W. Morgan Rd.
Ann Arbor,  MI  48108
Applicant Contact DAWN I MOORE
Correspondent
Arbor Technologies, Inc.
401 W. Morgan Rd.
Ann Arbor,  MI  48108
Correspondent Contact DAWN I MOORE
Regulation Number868.5130
Classification Product Code
BSN  
Date Received03/07/1996
Decision Date 04/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-