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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Electrosurgical
510(k) Number K853291
Device Name GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300
Applicant
Bio-Detek, Inc.
171 Forbes Blvd.
P.O. Box 809
Mansfield,  MA  02048
Applicant Contact DONALD C EPSTEIN
Correspondent
Bio-Detek, Inc.
171 Forbes Blvd.
P.O. Box 809
Mansfield,  MA  02048
Correspondent Contact DONALD C EPSTEIN
Regulation Number878.4400
Classification Product Code
HAM  
Date Received08/05/1985
Decision Date 10/10/1985
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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