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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blade, Saw, General & Plastic Surgery, Surgical
510(k) Number K861876
Device Name CRANIO BLADES AND WIRE PASS DRILL
Applicant
New England Surgical Instrument Corp.
P.O. Box 35
83 E. Water St.
Rockland,  MA  02370
Applicant Contact KATHLEEN M FEENEY
Correspondent
New England Surgical Instrument Corp.
P.O. Box 35
83 E. Water St.
Rockland,  MA  02370
Correspondent Contact KATHLEEN M FEENEY
Regulation Number878.4820
Classification Product Code
GFA  
Date Received05/15/1986
Decision Date 05/30/1986
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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