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 tube, tracheostomy (w/wo connector)
510(k) Number K945406
Device Name SSV PHONATE(TM) SHILEY SPEAKING VALVE
Applicant
MALLINCKRODT MEDICAL TPI, INC.
1595 DEERE AVE.
P.O. BOX 19614
IRVINE,  CA  92714
Applicant Contact ROBERT F INGHAM
Correspondent
MALLINCKRODT MEDICAL TPI, INC.
1595 DEERE AVE.
P.O. BOX 19614
IRVINE,  CA  92714
Correspondent Contact ROBERT F INGHAM
Regulation Number868.5800
Classification Product Code
BTO  
Date Received11/03/1994
Decision Date 02/27/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-