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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 K852184
Device Name ELECTRO-CAUTERY KNIFE CLEANER 6000 1
Applicant
DLP, INC.
P.O.BOX 409
620 WATSONS S.W.
GRAND RAPIDS,  MI  49501
Applicant Contact RONALD A WILLIAMS
Correspondent
DLP, INC.
P.O.BOX 409
620 WATSONS S.W.
GRAND RAPIDS,  MI  49501
Correspondent Contact RONALD A WILLIAMS
Regulation Number878.4400
Classification Product Code
HAM  
Date Received05/20/1985
Decision Date 06/04/1985
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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