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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 K945254
Device Name ELECTROSURGICAL CUTTING & COAGULATION DEVICE ACCESSORIES
Applicant
Endotec, Inc.
6550a Best Friend Rd.
Norcross,  GA  30071
Applicant Contact FREDDIE P ANDRIENI
Correspondent
Endotec, Inc.
6550a Best Friend Rd.
Norcross,  GA  30071
Correspondent Contact FREDDIE P ANDRIENI
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/28/1994
Decision Date 06/06/1995
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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