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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrosurgical, Active, Urological
510(k) Number K933174
Device Name GREENWALD FLEXIBLE ENDOSCOPIC ELECTRODE
Applicant
GREENWALD SURGICAL CO., INC.
2688 DEKALB ST.
LAKE STATION,  IN  46405
Applicant Contact CHRISTOPHER REYNOLDS
Correspondent
GREENWALD SURGICAL CO., INC.
2688 DEKALB ST.
LAKE STATION,  IN  46405
Correspondent Contact CHRISTOPHER REYNOLDS
Regulation Number876.4300
Classification Product Code
FAS  
Date Received06/29/1993
Decision Date 04/01/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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