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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 K945156
Device Name SLASE 210 PLUS HOLMIUM LASER SYSTEM
Applicant
New Star Lasers, Inc.
11802 Kemper Rd.
Auburn,  CA  95603
Applicant Contact LAURIE A RIDENER
Correspondent
New Star Lasers, Inc.
11802 Kemper Rd.
Auburn,  CA  95603
Correspondent Contact LAURIE A RIDENER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/21/1994
Decision Date 03/09/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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