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FDA 510(k)

REDUCED SHEAR OWR RECLINE SYSTEM

K-Number: K923362 · 1993-03-26

ApplicantLabac Systems, Inc.
Decision Date1993-03-26
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

REDUCED SHEAR OWR RECLINE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Labac Systems, Inc.. It received FDA 510(k) clearance on 1993-03-26 under 510(k) number K923362. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REDUCED SHEAR OWR RECLINE SYSTEM?

REDUCED SHEAR OWR RECLINE SYSTEM is a medical device that received FDA 510(k) clearance on 1993-03-26. The listed applicant is Labac Systems, Inc.. The 510(k) number is K923362.

When did REDUCED SHEAR OWR RECLINE SYSTEM receive FDA 510(k) clearance?

REDUCED SHEAR OWR RECLINE SYSTEM received FDA 510(k) clearance on 1993-03-26, under 510(k) number K923362.

Who is the listed applicant for REDUCED SHEAR OWR RECLINE SYSTEM?

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

What is the FDA product code for REDUCED SHEAR OWR RECLINE SYSTEM?

The FDA product code for REDUCED SHEAR OWR RECLINE SYSTEM is ITI.

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Other records listing Labac Systems, Inc. as applicant

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Related Devices (Code: ITI)

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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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