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FDA 510(k)

STRYKER ORAL MAX SYSTEM

K-Number: K954690 · 1996-08-20

ApplicantStryker Corp.
Decision Date1996-08-20
Product CodeDZI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STRYKER ORAL MAX SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corp.. It received FDA 510(k) clearance on 1996-08-20 under 510(k) number K954690. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRYKER ORAL MAX SYSTEM?

STRYKER ORAL MAX SYSTEM is a medical device that received FDA 510(k) clearance on 1996-08-20. The listed applicant is Stryker Corp.. The 510(k) number is K954690.

When did STRYKER ORAL MAX SYSTEM receive FDA 510(k) clearance?

STRYKER ORAL MAX SYSTEM received FDA 510(k) clearance on 1996-08-20, under 510(k) number K954690.

Who is the listed applicant for STRYKER ORAL MAX SYSTEM?

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

What is the FDA product code for STRYKER ORAL MAX SYSTEM?

The FDA product code for STRYKER ORAL MAX SYSTEM is DZI.

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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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