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 media, coupling, ultrasound
510(k) Number K112827
Device Name SHEATHES ULTRASOND GEL
Applicant
SHEATHING TECHNOLOGIES, INC.
18431 TECHNOLOGY DR.
MORGAN HILL,  CA  95037
Applicant Contact JENNIFER DOWNING
Correspondent
SHEATHING TECHNOLOGIES, INC.
18431 TECHNOLOGY DR.
MORGAN HILL,  CA  95037
Correspondent Contact JENNIFER DOWNING
Regulation Number892.1570
Classification Product Code
MUI  
Date Received09/28/2011
Decision Date 06/22/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-