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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K874154
Device Name ELECATH(R) TRANSESOPHAGEAL PACING CATHETER
Applicant
Electro-Catheter Corp.
2100 Felver Ct.
P.O. Box 1214c
Rahway,  NJ  07065
Applicant Contact RICHARD RAGULA
Correspondent
Electro-Catheter Corp.
2100 Felver Ct.
P.O. Box 1214c
Rahway,  NJ  07065
Correspondent Contact RICHARD RAGULA
Regulation Number876.5980
Classification Product Code
KNT  
Date Received10/13/1987
Decision Date 04/29/1988
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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