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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cautery, Thermal, Battery-Powered
510(k) Number K841325
Device Name REPLACE-A-TIP RECHARG. LOW TEMP.
Applicant
Suncoast Medical Manufacturers, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Suncoast Medical Manufacturers, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number886.4115
Classification Product Code
HQP  
Date Received04/02/1984
Decision Date 05/09/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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