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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 K895855
Device Name PHOENIX
Applicant
Medical and Scientific Enterprises, Inc.
29 Wall St.
Foxboro,  MA  02035
Applicant Contact PAUL NARDELLA
Correspondent
Medical and Scientific Enterprises, Inc.
29 Wall St.
Foxboro,  MA  02035
Correspondent Contact PAUL NARDELLA
Regulation Number876.4300
Classification Product Code
KNS  
Date Received10/02/1989
Decision Date 01/22/1990
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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