SHEATHES ULTRASOND GEL


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

Correspodent Contact jennifer downing
Regulation Number 892.1570
Classification Product Code
MUI  
Date Received 09/28/2011
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