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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
510(k) Number K093079
Device Name TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U
Applicant
Hobbs Medical, Inc.
8 Spring St.
Stafford Springs,  CT  06076
Applicant Contact EMILY MADSEN
Correspondent
Hobbs Medical, Inc.
8 Spring St.
Stafford Springs,  CT  06076
Correspondent Contact EMILY MADSEN
Regulation Number876.4300
Classification Product Code
KNS  
Date Received09/30/2009
Decision Date 08/02/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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