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FDA 510(k) Application Details - K961693
Device Classification Name
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
PLI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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