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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K925266
Device Name SUREPEN(TM) DISPOSABLE ACTIVE ELECTRODES
Applicant
Laser Surgical Systems
3052 Orchard Dr.
San Jose,  CA  95134
Applicant Contact DONNA PAGE
Correspondent
Laser Surgical Systems
3052 Orchard Dr.
San Jose,  CA  95134
Correspondent Contact DONNA PAGE
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/19/1992
Decision Date 04/15/1993
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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