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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Cautery, Radiofrequency, Ac-Powered
510(k) Number K955158
Device Name SURGITRON
Applicant
ELLMAN INTL., INC.
30 NORTHPORT RD.
SOUND BEACH,  NY  11789 -1734
Applicant Contact RICHARD C LANZILLOTTO
Correspondent
ELLMAN INTL., INC.
30 NORTHPORT RD.
SOUND BEACH,  NY  11789 -1734
Correspondent Contact RICHARD C LANZILLOTTO
Regulation Number886.4100
Classification Product Code
HQR  
Date Received11/13/1995
Decision Date 02/09/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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