DALE I.V. IDENTIFIER; PRODUCT #1125

Device, Intravascular Catheter Securement

DALE MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Dale Medical Products, Inc. with the FDA for Dale I.v. Identifier; Product #1125.

Pre-market Notification Details

Device IDK894586
510k NumberK894586
Device Name:DALE I.V. IDENTIFIER; PRODUCT #1125
ClassificationDevice, Intravascular Catheter Securement
Applicant DALE MEDICAL PRODUCTS, INC. 7 CROSS ST. P.O. BOX 1556 Plainville,  MA  02762
ContactDaniel Mcelaney
CorrespondentDaniel Mcelaney
DALE MEDICAL PRODUCTS, INC. 7 CROSS ST. P.O. BOX 1556 Plainville,  MA  02762
Product CodeKMK  
CFR Regulation Number880.5210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-07-24
Decision Date1989-08-15

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