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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 K962935
Device Name UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE
Applicant
Unimed Surgical Products, Inc.
10401 Belcher Rd.
Largo,  FL  34647
Applicant Contact RONALD R FROEMMING
Correspondent
Unimed Surgical Products, Inc.
10401 Belcher Rd.
Largo,  FL  34647
Correspondent Contact RONALD R FROEMMING
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/29/1996
Decision Date 09/03/1996
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
Recalls CDRH Recalls
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