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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 K885220
Device Name PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT
Applicant
ETHOX CORP.
251 SENECA ST.
BUFFALO,  NY  14204
Applicant Contact F JANKOWSKI
Correspondent
ETHOX CORP.
251 SENECA ST.
BUFFALO,  NY  14204
Correspondent Contact F JANKOWSKI
Regulation Number876.5980
Classification Product Code
KNT  
Date Received12/20/1988
Decision Date 09/25/1989
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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