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FDA 510(k)

ESPI REDUCER SLEEVE, #8415

K-Number: K903596 · 1990-09-12

ApplicantDixon Medical, Inc.
Decision Date1990-09-12
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ESPI REDUCER SLEEVE, #8415 is the device name listed in this FDA 510(k) record. The listed applicant is Dixon Medical, Inc.. It received FDA 510(k) clearance on 1990-09-12 under 510(k) number K903596. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESPI REDUCER SLEEVE, #8415?

ESPI REDUCER SLEEVE, #8415 is a medical device that received FDA 510(k) clearance on 1990-09-12. The listed applicant is Dixon Medical, Inc.. The 510(k) number is K903596.

When did ESPI REDUCER SLEEVE, #8415 receive FDA 510(k) clearance?

ESPI REDUCER SLEEVE, #8415 received FDA 510(k) clearance on 1990-09-12, under 510(k) number K903596.

Who is the listed applicant for ESPI REDUCER SLEEVE, #8415?

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

What is the FDA product code for ESPI REDUCER SLEEVE, #8415?

The FDA product code for ESPI REDUCER SLEEVE, #8415 is HET.

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Other records listing Dixon Medical, Inc. as applicant

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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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