FDA 510(k)

I.V. START KIT, STERILE, DISPOSABLES

K-Number: K863712 · 1986-10-22

ApplicantBusse Hospital Disposables, Inc.

Decision Date1986-10-22

Product CodeLRS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

I.V. START KIT, STERILE, DISPOSABLES is the device name listed in this FDA 510(k) record. The listed applicant is Busse Hospital Disposables, Inc.. It received FDA 510(k) clearance on 1986-10-22 under 510(k) number K863712. The device is classified under product code LRS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I.V. START KIT, STERILE, DISPOSABLES?

I.V. START KIT, STERILE, DISPOSABLES is a medical device that received FDA 510(k) clearance on 1986-10-22. The listed applicant is Busse Hospital Disposables, Inc.. The 510(k) number is K863712.

When did I.V. START KIT, STERILE, DISPOSABLES receive FDA 510(k) clearance?

I.V. START KIT, STERILE, DISPOSABLES received FDA 510(k) clearance on 1986-10-22, under 510(k) number K863712.

Who is the listed applicant for I.V. START KIT, STERILE, DISPOSABLES?

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

What is the FDA product code for I.V. START KIT, STERILE, DISPOSABLES?

The FDA product code for I.V. START KIT, STERILE, DISPOSABLES is LRS.

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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.