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FDA 510(k)

ESTIC MICROFILL

K-Number: K840176 · 1984-04-13

ApplicantKulzer, Inc.
Decision Date1984-04-13
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ESTIC MICROFILL is the device name listed in this FDA 510(k) record. The listed applicant is Kulzer, Inc.. It received FDA 510(k) clearance on 1984-04-13 under 510(k) number K840176. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESTIC MICROFILL?

ESTIC MICROFILL is a medical device that received FDA 510(k) clearance on 1984-04-13. The listed applicant is Kulzer, Inc.. The 510(k) number is K840176.

When did ESTIC MICROFILL receive FDA 510(k) clearance?

ESTIC MICROFILL received FDA 510(k) clearance on 1984-04-13, under 510(k) number K840176.

Who is the listed applicant for ESTIC MICROFILL?

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

What is the FDA product code for ESTIC MICROFILL?

The FDA product code for ESTIC MICROFILL is EBF.

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Other records listing Kulzer, Inc. as applicant

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Related Devices (Code: EBF)

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

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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