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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Electrosurgical
510(k) Number K820664
Device Name DISPOSABLE ELECTRODE
Applicant
TRIDENT SURGICAL CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
TRIDENT SURGICAL CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4400
Classification Product Code
HAM  
Date Received03/11/1982
Decision Date 03/19/1982
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
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