FDA 510(k) Application Details - K961693

Device Classification Name

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510(K) Number K961693
Device Name DALE GASTROSTOMY TUBE HOLDER
Applicant DALE MEDICAL PRODUCTS, INC.
7 CROSS ST.
P.O. BOX 1556
PLAINVILLE, MA 02762 US
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Contact EGIDIA M VERGANO
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Regulation Number

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Classification Product Code PLI
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Date Received 05/01/1996
Decision Date 07/30/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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