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 K963717
Device Name MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS)
Applicant
Millipore Corp.
80 Ashby Rd.
P.O. Box 9125
Bedford,  MA  01730
Applicant Contact THOMAS G BORROWS
Correspondent
Millipore Corp.
80 Ashby Rd.
P.O. Box 9125
Bedford,  MA  01730
Correspondent Contact THOMAS G BORROWS
Regulation Number868.5130
Classification Product Code
BSN  
Date Received09/16/1996
Decision Date 06/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-