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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dilator, esophageal
510(k) Number K883526
Device Name PORGES STEPPED NEOPLEX DILATOR
Applicant
PORGES CORP.
5700 west 23rd ave.
gary,  IN  46406
Applicant Contact harry m kaufman
Correspondent
PORGES CORP.
5700 west 23rd ave.
gary,  IN  46406
Correspodent Contact harry m kaufman
Regulation Number876.5365
Classification Product Code
KNQ  
Date Received08/18/1988
Decision Date 10/28/1988
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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