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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 K874825
Device Name DISPOSABLE CAUTERIES
Applicant
Midsouth Industries, Inc.
P.O. Box 322
Gadsden,  AL  35999
Applicant Contact GENE ZAMBA
Correspondent
Midsouth Industries, Inc.
P.O. Box 322
Gadsden,  AL  35999
Correspondent Contact GENE ZAMBA
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/25/1987
Decision Date 03/04/1988
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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