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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 K891109
Device Name PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE
Applicant
CONCEPT, INC.
11311 CONCEPT BLVD.
LARGO,  FL  34643
Applicant Contact MARTHA C MILLER
Correspondent
CONCEPT, INC.
11311 CONCEPT BLVD.
LARGO,  FL  34643
Correspondent Contact MARTHA C MILLER
Regulation Number876.5980
Classification Product Code
KNT  
Date Received03/02/1989
Decision Date 05/08/1989
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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