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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 K121162
Device Name POLARIS Q-SWITCH RUBY SYSTEM
Applicant
Sandstone Medical Technologies, LLC
105 Citation Ct.
Birmingham,  AL  35209
Applicant Contact MARK ROHRER
Correspondent
Sandstone Medical Technologies, LLC
105 Citation Ct.
Birmingham,  AL  35209
Correspondent Contact MARK ROHRER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/17/2012
Decision Date 07/18/2012
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
Predetermined Change
Control Plan Authorized		 No
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