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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K863731
Device Name ROTARY* POWERED SCALPEL
Applicant
Self Sharpening Surgical Steel, Inc.
3333 E. Jefferson
Detroit,  MI  48207
Applicant Contact GEORGE H MULLER,SCD
Correspondent
Self Sharpening Surgical Steel, Inc.
3333 E. Jefferson
Detroit,  MI  48207
Correspondent Contact GEORGE H MULLER,SCD
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/23/1986
Decision Date 10/17/1986
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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