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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 K993991
Device Name HM-930 ELECTROSURGICAL UNIT
Applicant
Hill-Med, Inc.
7217 NW 46th St.
Miami,  FL  33166
Applicant Contact JHOANA VASQUEZ
Correspondent
Hill-Med, Inc.
7217 NW 46th St.
Miami,  FL  33166
Correspondent Contact JHOANA VASQUEZ
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/24/1999
Decision Date 05/30/2000
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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