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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 K942577
Device Name SURGICAL TIP CLEANER
Applicant
White Knight Healthcare
P.O. Box 6874
175 Deaverview Rd.
Asheville,  NC  28816
Applicant Contact FRANK DASTOLI
Correspondent
White Knight Healthcare
P.O. Box 6874
175 Deaverview Rd.
Asheville,  NC  28816
Correspondent Contact FRANK DASTOLI
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/31/1994
Decision Date 07/26/1994
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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