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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 K905117
Device Name ENDOSCOPE AND ACCESSORIES
Applicant
NORTHGATE TECHNOLOGIES, INC.
3930 VENTURA DR.
ARLINGTON HEIGHTS,  IL  60004
Applicant Contact SAMUELLA D EMRICH
Correspondent
NORTHGATE TECHNOLOGIES, INC.
3930 VENTURA DR.
ARLINGTON HEIGHTS,  IL  60004
Correspondent Contact SAMUELLA D EMRICH
Regulation Number876.1500
Classification Product Code
GCI  
Date Received11/13/1990
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
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