EMBRACE GEL


Device Classification Name

media,coupling,ultrasound

510(k) Number K072515
Device Name EMBRACE GEL
Applicant
ORISON CORPORATION
121 boone ridge dr.
johnson city, 
TN 
37601

Applicant Contact al sandy
Regulation Number 892.1570
Classification Product Code
MUI  
Date Received 09/07/2007
Decision Date 09/20/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No