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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Knife, Surgical
510(k) Number K861947
Device Name SURGICAL KNIFE
Applicant
Sharpoint, Inc.
2850 Windmill Rd.
Reading,  PA  19608
Applicant Contact DAVID A YATES
Correspondent
Sharpoint, Inc.
2850 Windmill Rd.
Reading,  PA  19608
Correspondent Contact DAVID A YATES
Regulation Number878.4800
Classification Product Code
EMF  
Date Received05/20/1986
Decision Date 06/06/1986
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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