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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 K894396
Device Name SURGILASE 25, 40, 45, 55, 60, 80, 100 LASER
Applicant
Surgilase, Inc.
I-95 Corporate Park
33 Plan Way
Warwick,  RI  02866
Applicant Contact MARGUERITE MCHENRY
Correspondent
Surgilase, Inc.
I-95 Corporate Park
33 Plan Way
Warwick,  RI  02866
Correspondent Contact MARGUERITE MCHENRY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/17/1989
Decision Date 08/07/1989
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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