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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 K841459
Device Name REPLACE-A-TIP ADJUST. LOW TEMP.-
Applicant
Suncoast Medical Manufacturers, Inc.
P.O. Box 3345
Clearwater,  FL  33515
Applicant Contact DAVID L JOHNS
Correspondent
Suncoast Medical Manufacturers, Inc.
P.O. Box 3345
Clearwater,  FL  33515
Correspondent Contact DAVID L JOHNS
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/09/1984
Decision Date 12/07/1984
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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