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 Mask, Oxygen
510(k) Number K913501
Device Name TRACHEOSTOMY MASK
Applicant
B & F MEDICAL PRODUCTS, INC.
1421 N. EXPRESSWAY DR.
TOLEDO,  OH  43608
Applicant Contact JIM SPILLIS
Correspondent
B & F MEDICAL PRODUCTS, INC.
1421 N. EXPRESSWAY DR.
TOLEDO,  OH  43608
Correspondent Contact JIM SPILLIS
Regulation Number868.5580
Classification Product Code
BYG  
Date Received08/07/1991
Decision Date 01/13/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-