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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 K002257
Device Name TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100
Applicant
Tecno Instruments (Pvt.) , Ltd.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
Tecno Instruments (Pvt.) , Ltd.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/25/2000
Decision Date 10/19/2000
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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