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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 K912637
Device Name LAPAROSCOPIC ELECTROSURGICAL CANNULA W/RETRACTABLE
Applicant
Dexide, Inc.
P.O. Box 185789
Fort Worth,  TX  76181
Applicant Contact KEITH JUNG
Correspondent
Dexide, Inc.
P.O. Box 185789
Fort Worth,  TX  76181
Correspondent Contact KEITH JUNG
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/14/1991
Decision Date 10/04/1991
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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