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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 K911312
Device Name SUCTION/IRRIGATION TUBE & TUBE WITH CHANNEL
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 Number878.4400
Classification Product Code
GEI  
Date Received03/25/1991
Decision Date 09/19/1991
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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