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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 K843974
Device Name VARIABLE TEMPERATURE CAUTERY DEVICE
Applicant
National Patent Development Corp.
783 Jersey Ave.
New Brunswick,  NJ  08901
Applicant Contact ALBERT A GHIGNONE
Correspondent
National Patent Development Corp.
783 Jersey Ave.
New Brunswick,  NJ  08901
Correspondent Contact ALBERT A GHIGNONE
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/11/1984
Decision Date 02/26/1985
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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