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510(k) K961693

Device
DALE GASTROSTOMY TUBE HOLDER
Applicant
DALE MEDICAL PRODUCTS, INC.
510(k) number
K961693
Product code
PLI  
Decision
Substantially Equivalent (SESE)
Decision date
1996-07-30
Date received
1996-05-01
Regulation
876.5980
Classification name
Gastrointestional Tube Holder
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
EGIDIA M VERGANO
Address
7 Cross St. P.O. Box 1556 Plainville MA US 02762 02762

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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