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FDA 510(k)

BURRON AMBULATORY DRUG DELIVERY SYSTEM

K-Number: K896422 · 1990-05-09

ApplicantBurron Medical, Inc.
Decision Date1990-05-09
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BURRON AMBULATORY DRUG DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Burron Medical, Inc.. It received FDA 510(k) clearance on 1990-05-09 under 510(k) number K896422. 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 BURRON AMBULATORY DRUG DELIVERY SYSTEM?

BURRON AMBULATORY DRUG DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1990-05-09. The listed applicant is Burron Medical, Inc.. The 510(k) number is K896422.

When did BURRON AMBULATORY DRUG DELIVERY SYSTEM receive FDA 510(k) clearance?

BURRON AMBULATORY DRUG DELIVERY SYSTEM received FDA 510(k) clearance on 1990-05-09, under 510(k) number K896422.

Who is the listed applicant for BURRON AMBULATORY DRUG DELIVERY SYSTEM?

The FDA 510(k) record lists Burron Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BURRON AMBULATORY DRUG DELIVERY SYSTEM?

The FDA product code for BURRON AMBULATORY DRUG DELIVERY SYSTEM is FRN.

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Other records listing Burron Medical, Inc. as applicant

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K902401CELSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEMK884235COMBITRANS DISPOSABLE PRESSURE TRANSDUCER KITK895191ANTI-THROMBOGENIC COATING FOR CATHETERSK895192SPINOCAN(R) CONTINUOUS SPINAL TRAYK884183BURRON TEFLON-COATED GUIDEWIREK882106PERFUSOR M SYRINGE PUMP

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Related Devices (Code: 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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