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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Motor, Surgical Instrument, Ac-Powered
510(k) Number K925360
Device Name ES-100 POWER SYSTEM, ES-100 SERIES
Applicant
Elekta Instruments, Inc.
1926 Northlake Pkwy.
Tucker,  GA  30084
Applicant Contact MARC BUNTAINE
Correspondent
Elekta Instruments, Inc.
1926 Northlake Pkwy.
Tucker,  GA  30084
Correspondent Contact MARC BUNTAINE
Regulation Number878.4820
Classification Product Code
GEY  
Date Received10/22/1992
Decision Date 09/07/1993
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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