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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 K921671
Device Name SURGILASE FIBERLASE VCO2 LASER WAVEGUIDE
Applicant
Surgical Products Corp.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Applicant Contact LYNNNE ARONSON
Correspondent
Surgical Products Corp.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Correspondent Contact LYNNNE ARONSON
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/08/1992
Decision Date 06/18/1992
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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