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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 K861614
Device Name GHI WET PENCIL
Applicant
Surgical Products Corp.
W140 N5446 Lilly Rd.
Menominee Fall,  WI  53051
Applicant Contact THOMAS RILEY
Correspondent
Surgical Products Corp.
W140 N5446 Lilly Rd.
Menominee Fall,  WI  53051
Correspondent Contact THOMAS RILEY
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/29/1986
Decision Date 07/08/1986
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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