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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 K880859
Device Name SURGICAL BURS
Applicant
New England Surgical Instrument Corp.
P.O. Box 35
83 E. Water St.
Rockland,  MA  02370
Applicant Contact RICHARD M BEANE
Correspondent
New England Surgical Instrument Corp.
P.O. Box 35
83 E. Water St.
Rockland,  MA  02370
Correspondent Contact RICHARD M BEANE
Regulation Number878.4820
Classification Product Code
GFF  
Date Received03/01/1988
Decision Date 03/21/1988
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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