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FDA 510(k)

PANCRETEC I.V. MODEL 5500 INFUSER

K-Number: K913719 · 1991-10-30

ApplicantAbbott Laboratories
Decision Date1991-10-30
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PANCRETEC I.V. MODEL 5500 INFUSER is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1991-10-30 under 510(k) number K913719. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PANCRETEC I.V. MODEL 5500 INFUSER?

PANCRETEC I.V. MODEL 5500 INFUSER is a medical device that received FDA 510(k) clearance on 1991-10-30. The listed applicant is Abbott Laboratories. The 510(k) number is K913719.

When did PANCRETEC I.V. MODEL 5500 INFUSER receive FDA 510(k) clearance?

PANCRETEC I.V. MODEL 5500 INFUSER received FDA 510(k) clearance on 1991-10-30, under 510(k) number K913719.

Who is the listed applicant for PANCRETEC I.V. MODEL 5500 INFUSER?

The FDA 510(k) record lists Abbott Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PANCRETEC I.V. MODEL 5500 INFUSER?

The FDA product code for PANCRETEC I.V. MODEL 5500 INFUSER is FRN.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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