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 K962133
Device Name EXPANDACELL INJECTO-PAK
Applicant
SHIPPERT MEDICAL TECHNOLOGIES CORP.
7002 SOUTH REVERE PARKWAY,
SUITE 60
ENGLEWOOD,  CO  80112
Applicant Contact SARAH M LAKE
Correspondent
SHIPPERT MEDICAL TECHNOLOGIES CORP.
7002 SOUTH REVERE PARKWAY,
SUITE 60
ENGLEWOOD,  CO  80112
Correspondent Contact SARAH M LAKE
Regulation Number874.4100
Classification Product Code
EMX  
Date Received06/03/1996
Decision Date 08/01/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-