ISOELASTICU


Device Classification Name

prosthesis, wrist, hemi-, ulnar

510(k) Number K081025
Device Name ISOELASTICU
Applicant
REMI SCIENCES, INC.
745 bent creek drive
lititz, 
PA 
17543

Applicant Contact sanjiv h naidu
Correspondent
REMI SCIENCES, INC.
745 bent creek drive
lititz, 
PA 
17543

Correspodent Contact sanjiv h naidu
Regulation Number 888.3810
Classification Product Code
KXE  
Date Received 04/10/2008
Decision Date 11/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No