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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Electrosurgical, And Accessories, Dental
510(k) Number K925116
Device Name ELECTROSURGICAL ELECTRODE
Applicant
Premier
1710 Romano Dr.
P.O. Box 111
Norristown,  PA  19404
Applicant Contact WILLIAM J FREZEL
Correspondent
Premier
1710 Romano Dr.
P.O. Box 111
Norristown,  PA  19404
Correspondent Contact WILLIAM J FREZEL
Regulation Number872.4920
Classification Product Code
EKZ  
Subsequent Product Code
JOS  
Date Received10/09/1992
Decision Date 03/01/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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