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 K924191
Device Name TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL
Applicant
American Healthcare Corp.
One American Healthcare Plz.
3611 Kennedy Rd.
South Plainfield,  NJ  07080
Applicant Contact RALPH S JARRETT
Correspondent
American Healthcare Corp.
One American Healthcare Plz.
3611 Kennedy Rd.
South Plainfield,  NJ  07080
Correspondent Contact RALPH S JARRETT
Regulation Number868.5800
Classification Product Code
BTO  
Date Received08/20/1992
Decision Date 04/02/1993
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-