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FDA 510(k)

FLEXIFLO-II

K-Number: K821661 · 1982-06-22

ApplicantAbbott Laboratories
Decision Date1982-06-22
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FLEXIFLO-II is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1982-06-22 under 510(k) number K821661. 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 FLEXIFLO-II?

FLEXIFLO-II is a medical device that received FDA 510(k) clearance on 1982-06-22. The listed applicant is Abbott Laboratories. The 510(k) number is K821661.

When did FLEXIFLO-II receive FDA 510(k) clearance?

FLEXIFLO-II received FDA 510(k) clearance on 1982-06-22, under 510(k) number K821661.

Who is the listed applicant for FLEXIFLO-II?

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 FLEXIFLO-II?

The FDA product code for FLEXIFLO-II 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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