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FDA 510(k)

SHEATHES (NON-LATEX)

K-Number: K963831 · 1997-02-10

ApplicantMedical Resources
Decision Date1997-02-10
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SHEATHES (NON-LATEX) is the device name listed in this FDA 510(k) record. The listed applicant is Medical Resources. It received FDA 510(k) clearance on 1997-02-10 under 510(k) number K963831. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHEATHES (NON-LATEX)?

SHEATHES (NON-LATEX) is a medical device that received FDA 510(k) clearance on 1997-02-10. The listed applicant is Medical Resources. The 510(k) number is K963831.

When did SHEATHES (NON-LATEX) receive FDA 510(k) clearance?

SHEATHES (NON-LATEX) received FDA 510(k) clearance on 1997-02-10, under 510(k) number K963831.

Who is the listed applicant for SHEATHES (NON-LATEX)?

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

What is the FDA product code for SHEATHES (NON-LATEX)?

The FDA product code for SHEATHES (NON-LATEX) is ITX.

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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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