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FDA 510(k)

STENODOC

K-Number: K946349 · 1996-05-24

ApplicantSpecs USA, Inc.
Decision Date1996-05-24
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

STENODOC is the device name listed in this FDA 510(k) record. The listed applicant is Specs USA, Inc.. It received FDA 510(k) clearance on 1996-05-24 under 510(k) number K946349. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STENODOC?

STENODOC is a medical device that received FDA 510(k) clearance on 1996-05-24. The listed applicant is Specs USA, Inc.. The 510(k) number is K946349.

When did STENODOC receive FDA 510(k) clearance?

STENODOC received FDA 510(k) clearance on 1996-05-24, under 510(k) number K946349.

Who is the listed applicant for STENODOC?

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

What is the FDA product code for STENODOC?

The FDA product code for STENODOC is IYO.

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.

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Other records listing Specs USA, 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.

K993027ESKA MODULAR HIP SYSTEM

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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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