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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 K120416
Device Name INSULATION TESTER
Applicant
Spectrum Surgical Supply Corp.
4575 Hudson Dr.
Stow,  OH  44224
Applicant Contact DENNIS A KOVIT
Correspondent
Spectrum Surgical Supply Corp.
4575 Hudson Dr.
Stow,  OH  44224
Correspondent Contact DENNIS A KOVIT
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/10/2012
Decision Date 03/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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