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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 K103667
Device Name SAPPHIRE ST PORTABLE DIODE LASER
Applicant
Den-Mat Holdings, LLC
2727 Skyway Dr.
Santa Maria,  CA  93455
Applicant Contact ALAN B MATTHEWS
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/15/2010
Decision Date 12/29/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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