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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name powered laser surgical instrument
510(k) Number K082101
Device Name LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE
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
Correspondent Contact MARK ROHRER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/25/2008
Decision Date 11/05/2008
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
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