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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 K913881
Device Name ENDOSTAT ELECTROSURGICAL UNIT
Applicant
Medical and Scientific Enterprises, Inc.
C/O Medical Device Consultants
45 W. St., Suite 2
Attleboro,  MA  02703
Applicant Contact LLYNNE ARONSON
Correspondent
Medical and Scientific Enterprises, Inc.
C/O Medical Device Consultants
45 W. St., Suite 2
Attleboro,  MA  02703
Correspondent Contact LLYNNE ARONSON
Regulation Number876.4300
Classification Product Code
KNS  
Date Received08/29/1991
Decision Date 11/01/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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