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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 K030339
Device Name CAUTERY TIP CLEANER, MODEL-TC-100
Applicant
Aspen Surgical Products, Inc.
7425 Clyde Park, Suite G
Byron Center,  MI  49315
Applicant Contact DEBBIE DALY
Correspondent
Aspen Surgical Products, Inc.
7425 Clyde Park, Suite G
Byron Center,  MI  49315
Correspondent Contact DEBBIE DALY
Regulation Number878.4400
Classification Product Code
GEI  
Date Received01/31/2003
Decision Date 03/07/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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