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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Nasogastric
510(k) Number K933596
Device Name GASTRIC, CATHETER, IRRIGATION & ASPIRATION
Applicant
Polamedco, Inc.
8295 S.La Cienega Blvd.
Inglewood,  CA  90301 -1521
Applicant Contact JERRY W HARRER
Correspondent
Polamedco, Inc.
8295 S.La Cienega Blvd.
Inglewood,  CA  90301 -1521
Correspondent Contact JERRY W HARRER
Regulation Number876.5980
Classification Product Code
BSS  
Date Received07/26/1993
Decision Date 02/13/1995
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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