SET FOR ASEPTIC DECANTING OF A FLEX I.V

Container, I.v.

DIP, INC.

The following data is part of a premarket notification filed by Dip, Inc. with the FDA for Set For Aseptic Decanting Of A Flex I.v.

Pre-market Notification Details

Device IDK812852
510k NumberK812852
Device Name:SET FOR ASEPTIC DECANTING OF A FLEX I.V
ClassificationContainer, I.v.
Applicant DIP, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKPE  
CFR Regulation Number880.5025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-10-13
Decision Date1981-11-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20613994900443 K812852 000
20613994900429 K812852 000
20613994887553 K812852 000
20613994887546 K812852 000

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