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FDA 510(k)

FLO-GARD(R) 6301

K-Number: K915523 · 1992-02-28

ApplicantBaxter Healthcare Corp
Decision Date1992-02-28
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FLO-GARD(R) 6301 is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1992-02-28 under 510(k) number K915523. 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 FLO-GARD(R) 6301?

FLO-GARD(R) 6301 is a medical device that received FDA 510(k) clearance on 1992-02-28. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K915523.

When did FLO-GARD(R) 6301 receive FDA 510(k) clearance?

FLO-GARD(R) 6301 received FDA 510(k) clearance on 1992-02-28, under 510(k) number K915523.

Who is the listed applicant for FLO-GARD(R) 6301?

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

What is the FDA product code for FLO-GARD(R) 6301?

The FDA product code for FLO-GARD(R) 6301 is FRN.

Other records listing Baxter Healthcare Corp as applicant

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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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