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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrosurgical
510(k) Number K000333
Device Name STANDARD & EXTENDED BLADE, STANDARD & EXTENDED NEEDLE, STANDARD & EXTENDED BALL, MODIFIED STANDARD & EXTENDED BLADE, MOD
Applicant
Triad Surgical Technologies, Inc.
7786 Prospector Dr.
Salt Lake City,  UT  84121
Applicant Contact BRIAN MCGAVIN
Correspondent
Triad Surgical Technologies, Inc.
7786 Prospector Dr.
Salt Lake City,  UT  84121
Correspondent Contact BRIAN MCGAVIN
Regulation Number878.4400
Classification Product Code
JOS  
Date Received02/03/2000
Decision Date 05/03/2000
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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