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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Exhaust, Surgical
510(k) Number K894765
Device Name SHARPLAN SMOKE EVACUATION UNIT, MODEL 100
Applicant
Laser Industries , Ltd.
1 Pearl Ct.
Allendale,  NJ  07401
Applicant Contact MARK PLOTTS
Correspondent
Laser Industries , Ltd.
1 Pearl Ct.
Allendale,  NJ  07401
Correspondent Contact MARK PLOTTS
Regulation Number878.5070
Classification Product Code
FYD  
Date Received07/26/1989
Decision Date 09/28/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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