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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 K944437
Device Name DISPOSABLE LASER SWEEP TIP
Applicant
Reliant Technologies, Inc.
1153 Triton Dr.
Suite C
Foster City,  CA  94404
Applicant Contact LANA BLACK
Correspondent
Reliant Technologies, Inc.
1153 Triton Dr.
Suite C
Foster City,  CA  94404
Correspondent Contact LANA BLACK
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/12/1994
Decision Date 03/14/1995
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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