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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bur, Surgical, General & Plastic Surgery
510(k) Number K853658
Device Name BURS FOR MICRO SURGICAL DRILL SYSTEM
Applicant
Acumed Instruments Corp.
345 Puente Dr.
Santa Barbara,  CA  93110
Applicant Contact DAVE ESSLINGER
Correspondent
Acumed Instruments Corp.
345 Puente Dr.
Santa Barbara,  CA  93110
Correspondent Contact DAVE ESSLINGER
Regulation Number878.4820
Classification Product Code
GFF  
Date Received09/03/1985
Decision Date 09/24/1985
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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