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FDA 510(k)

3-DAY RELEASE OF ETHYLENE OXIDE DEVICE

K-Number: K832352 · 1984-01-13

ApplicantParke-Davis Co.
Decision Date1984-01-13
Product CodeBSO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

3-DAY RELEASE OF ETHYLENE OXIDE DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Parke-Davis Co.. It received FDA 510(k) clearance on 1984-01-13 under 510(k) number K832352. The device is classified under product code BSO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3-DAY RELEASE OF ETHYLENE OXIDE DEVICE?

3-DAY RELEASE OF ETHYLENE OXIDE DEVICE is a medical device that received FDA 510(k) clearance on 1984-01-13. The listed applicant is Parke-Davis Co.. The 510(k) number is K832352.

When did 3-DAY RELEASE OF ETHYLENE OXIDE DEVICE receive FDA 510(k) clearance?

3-DAY RELEASE OF ETHYLENE OXIDE DEVICE received FDA 510(k) clearance on 1984-01-13, under 510(k) number K832352.

Who is the listed applicant for 3-DAY RELEASE OF ETHYLENE OXIDE DEVICE?

The FDA 510(k) record lists Parke-Davis Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3-DAY RELEASE OF ETHYLENE OXIDE DEVICE?

The FDA product code for 3-DAY RELEASE OF ETHYLENE OXIDE DEVICE is BSO.

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Related Devices (Code: BSO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241410EDEN ControlCathJmt Co., Ltd.K231242Perifix FX Catheter; Contiplex FX CatheterB.Braun Medical, Inc.K230603Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002)Teleflex MedicalK193664SubQKath Catheter and Needle SetHk SurgicalK200624Percutaneous IntroducerEpimed International, Inc.K191470C-CAT Anaesthesia Catheter kitCimpax Aps

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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