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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 K924720
Device Name VISIDISC KITS, SPINESCOPE
Applicant
Laserscope
3052 Orchard Dr.
San Jose,  CA  95134
Applicant Contact DONNA PAGE
Correspondent
Laserscope
3052 Orchard Dr.
San Jose,  CA  95134
Correspondent Contact DONNA PAGE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/21/1992
Decision Date 10/08/1993
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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