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FDA 510(k)

BBL GASPAK POUCH

K-Number: K841307 · 1984-05-14

Decision Date1984-05-14
Product CodeFKJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BBL GASPAK POUCH is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1984-05-14 under 510(k) number K841307. The device is classified under product code FKJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BBL GASPAK POUCH?

BBL GASPAK POUCH is a medical device that received FDA 510(k) clearance on 1984-05-14. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K841307.

When did BBL GASPAK POUCH receive FDA 510(k) clearance?

BBL GASPAK POUCH received FDA 510(k) clearance on 1984-05-14, under 510(k) number K841307.

Who is the listed applicant for BBL GASPAK POUCH?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BBL GASPAK POUCH?

The FDA product code for BBL GASPAK POUCH is FKJ.

Related Clinical Trials

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.

Other records listing Bd Becton Dickinson Vacutainer Systems Preanalytic as applicant

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.

View all 632 devices →

Related Devices (Code: FKJ)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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