FDA 510(k)

SHARPSAFE CAT. NO. 4127

K-Number: K935628 · 1994-02-04

ApplicantSmiths Industries Medical Systems, Inc.

Decision Date1994-02-04

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SHARPSAFE CAT. NO. 4127 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 1994-02-04 under 510(k) number K935628. 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. 4127?

SHARPSAFE CAT. NO. 4127 is a medical device that received FDA 510(k) clearance on 1994-02-04. The listed applicant is Smiths Industries Medical Systems, Inc.. The 510(k) number is K935628.

When did SHARPSAFE CAT. NO. 4127 receive FDA 510(k) clearance?

SHARPSAFE CAT. NO. 4127 received FDA 510(k) clearance on 1994-02-04, under 510(k) number K935628.

Who is the listed applicant for SHARPSAFE CAT. NO. 4127?

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. 4127?

The FDA product code for SHARPSAFE CAT. NO. 4127 is FMI.

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Related Devices (Code: FMI)

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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.