X-VOID, SPIDER


Device Classification Name

arthroscope

510(k) Number K072198
Device Name X-VOID, SPIDER
Applicant
SINTEA BIOTECH, INC.
407 lincoln rd. suite 10l
miami beach, 
FL 
33139

Applicant Contact gustavo a rios
Correspondent
SINTEA BIOTECH, INC.
407 lincoln rd. suite 10l
miami beach, 
FL 
33139

Correspodent Contact gustavo a rios
Regulation Number 888.1100
Classification Product Code
HRX  
Subsequent Product Codes
HXG   OAR  
Date Received 08/07/2007
Decision Date 06/06/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No