TRIPLEX ER. YAG / ND: YAG SYSTEM


Device Classification Name

powered laser surgical instrument

510(k) Number K110502
Device Name TRIPLEX ER. YAG / ND: YAG SYSTEM
Applicant
SANDSTONE MEDICAL TECHNOLOGIES, LLC
105 citation court
homewood, 
AL 
35209

Applicant Contact mark rohrer
Correspondent
SANDSTONE MEDICAL TECHNOLOGIES, LLC
105 citation court
homewood, 
AL 
35209

Correspodent Contact mark rohrer
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 02/22/2011
Decision Date 04/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No