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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chisel, Osteotome, Surgical
510(k) Number K864775
Device Name CHISEL (OSTEOTOME, GOUGE, ETC.)
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 Number872.4565
Classification Product Code
EMM  
Date Received12/05/1986
Decision Date 02/12/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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