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 And Tube Cuff
510(k) Number K133528
Device Name H&H EMERGENCY CRICOTHYROTOMY KIT
Applicant
H&H MEDICAL CORPORATION
290 TURNPIKE RD.
SUITE 200
WESTBOROUGH,  MA  01581
Applicant Contact J. Lawrence Stevens
Correspondent
H&H MEDICAL CORPORATION
290 TURNPIKE RD.
SUITE 200
WESTBOROUGH,  MA  01581
Correspondent Contact J. Lawrence Stevens
Regulation Number868.5800
Classification Product Code
JOH  
Date Received11/15/2013
Decision Date 07/03/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-