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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 K001253
Device Name SURGITRON IEC II
Applicant
Ellman Intl., Inc.
1135 Railroad Ave.,
Ellman Bldg.
Hewlett,  NY  11557
Applicant Contact FRANK LIN
Correspondent
Ellman Intl., Inc.
1135 Railroad Ave.,
Ellman Bldg.
Hewlett,  NY  11557
Correspondent Contact FRANK LIN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/19/2000
Decision Date 05/26/2000
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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