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FDA 510(k)

SCOPETEX(TM)

K-Number: K945590 · 1997-05-20

ApplicantSmith Helms Mulliss & Moore, L.L.P.
Decision Date1997-05-20
Product CodeCCW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SCOPETEX(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Smith Helms Mulliss & Moore, L.L.P.. It received FDA 510(k) clearance on 1997-05-20 under 510(k) number K945590. The device is classified under product code CCW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCOPETEX(TM)?

SCOPETEX(TM) is a medical device that received FDA 510(k) clearance on 1997-05-20. The listed applicant is Smith Helms Mulliss & Moore, L.L.P.. The 510(k) number is K945590.

When did SCOPETEX(TM) receive FDA 510(k) clearance?

SCOPETEX(TM) received FDA 510(k) clearance on 1997-05-20, under 510(k) number K945590.

Who is the listed applicant for SCOPETEX(TM)?

The FDA 510(k) record lists Smith Helms Mulliss & Moore, L.L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCOPETEX(TM)?

The FDA product code for SCOPETEX(TM) is CCW.

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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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