FDA 510(k)

SHARPSAFE, CAT. NO. 4125

K-Number: K935777 · 1994-02-28

ApplicantSmiths Industries Medical Systems, Inc.

Decision Date1994-02-28

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SHARPSAFE, CAT. NO. 4125 is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Industries Medical Systems, Inc.. It received FDA 510(k) clearance on 1994-02-28 under 510(k) number K935777. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHARPSAFE, CAT. NO. 4125?

SHARPSAFE, CAT. NO. 4125 is a medical device that received FDA 510(k) clearance on 1994-02-28. The listed applicant is Smiths Industries Medical Systems, Inc.. The 510(k) number is K935777.

When did SHARPSAFE, CAT. NO. 4125 receive FDA 510(k) clearance?

SHARPSAFE, CAT. NO. 4125 received FDA 510(k) clearance on 1994-02-28, under 510(k) number K935777.

Who is the listed applicant for SHARPSAFE, CAT. NO. 4125?

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

What is the FDA product code for SHARPSAFE, CAT. NO. 4125?

The FDA product code for SHARPSAFE, CAT. NO. 4125 is FMI.

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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.