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FDA 510(k)

SPOMA INTERNATIONAL CORPORATION

K-Number: K943352 · 1994-08-05

ApplicantSpoma Intl. Corp.
Decision Date1994-08-05
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SPOMA INTERNATIONAL CORPORATION is the device name listed in this FDA 510(k) record. The listed applicant is Spoma Intl. Corp.. It received FDA 510(k) clearance on 1994-08-05 under 510(k) number K943352. The device is classified under product code HQY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPOMA INTERNATIONAL CORPORATION?

SPOMA INTERNATIONAL CORPORATION is a medical device that received FDA 510(k) clearance on 1994-08-05. The listed applicant is Spoma Intl. Corp.. The 510(k) number is K943352.

When did SPOMA INTERNATIONAL CORPORATION receive FDA 510(k) clearance?

SPOMA INTERNATIONAL CORPORATION received FDA 510(k) clearance on 1994-08-05, under 510(k) number K943352.

Who is the listed applicant for SPOMA INTERNATIONAL CORPORATION?

The FDA 510(k) record lists Spoma Intl. Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPOMA INTERNATIONAL CORPORATION?

The FDA product code for SPOMA INTERNATIONAL CORPORATION is HQY.

Related Clinical Trials

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Related Devices (Code: HQY)

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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