INQU PASTE MIX


Device Classification Name

filler, bone void, calcium compound

510(k) Number K111838
Device Name INQU PASTE MIX
Applicant
ISTO TECHNOLOGIES, INC.
5600 wisconsin ave.
#509
chevy chase, 
MD 
20815

Applicant Contact patsy j trisler
Correspondent
ISTO TECHNOLOGIES, INC.
5600 wisconsin ave.
#509
chevy chase, 
MD 
20815

Correspodent Contact patsy j trisler
Regulation Number 888.3045
Classification Product Code
MQV  
Date Received 06/29/2011
Decision Date 09/26/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No