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 Balloon, Epistaxis
510(k) Number K935724
Device Name THE EXPANDACELL SINUS PACK
Applicant
DENVER SPLINT CO.
7002 SOUTH REVERE PARKWAY,
SUITE 60
ENGLEWOOD,  CO  80112
Applicant Contact SARAH M LAKE
Correspondent
DENVER SPLINT CO.
7002 SOUTH REVERE PARKWAY,
SUITE 60
ENGLEWOOD,  CO  80112
Correspondent Contact SARAH M LAKE
Regulation Number874.4100
Classification Product Code
EMX  
Date Received12/01/1993
Decision Date 05/12/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-