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FDA 510(k)

MINI-PUMP U-100

K-Number: K840616 · 1984-03-30

ApplicantAdvanced Bio Systems, Inc.
Decision Date1984-03-30
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MINI-PUMP U-100 is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Bio Systems, Inc.. It received FDA 510(k) clearance on 1984-03-30 under 510(k) number K840616. 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 MINI-PUMP U-100?

MINI-PUMP U-100 is a medical device that received FDA 510(k) clearance on 1984-03-30. The listed applicant is Advanced Bio Systems, Inc.. The 510(k) number is K840616.

When did MINI-PUMP U-100 receive FDA 510(k) clearance?

MINI-PUMP U-100 received FDA 510(k) clearance on 1984-03-30, under 510(k) number K840616.

Who is the listed applicant for MINI-PUMP U-100?

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

What is the FDA product code for MINI-PUMP U-100?

The FDA product code for MINI-PUMP U-100 is FRN.

Other records listing Advanced Bio Systems, Inc. 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.

K844480DENTAL ORAL CARE SYSTEMS & COMPONENTS

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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.

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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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