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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocautery, Gynecologic (And Accessories)
510(k) Number K944450
Device Name SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE
Applicant
Unimed Surgical Products, Inc.
10401 Belcher Rd.
Largo,  FL  34647
Applicant Contact LORNA K LINVILLE
Correspondent
Unimed Surgical Products, Inc.
10401 Belcher Rd.
Largo,  FL  34647
Correspondent Contact LORNA K LINVILLE
Regulation Number884.4120
Classification Product Code
HGI  
Date Received09/12/1994
Decision Date 07/25/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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