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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laryngoscope, Endoscope
510(k) Number K911461
Device Name SURGITRON
Applicant
Ellman Intl. Mfg., Inc.
1135 Railroad Ave.
Hewlett,  NY  11557
Applicant Contact RICHARD LANZILLOTTO
Correspondent
Ellman Intl. Mfg., Inc.
1135 Railroad Ave.
Hewlett,  NY  11557
Correspondent Contact RICHARD LANZILLOTTO
Regulation Number876.1500
Classification Product Code
GCI  
Date Received04/03/1991
Decision Date 04/25/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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