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FDA 510(k)

SLIP-ON FIXATION SPLINT (SFS)

K-Number: K934468 · 1994-08-05

ApplicantGatewood Splints
Decision Date1994-08-05
Product CodeEHO
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SLIP-ON FIXATION SPLINT (SFS) is the device name listed in this FDA 510(k) record. The listed applicant is Gatewood Splints. It received FDA 510(k) clearance on 1994-08-05 under 510(k) number K934468. The device is classified under product code EHO. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLIP-ON FIXATION SPLINT (SFS)?

SLIP-ON FIXATION SPLINT (SFS) is a medical device that received FDA 510(k) clearance on 1994-08-05. The listed applicant is Gatewood Splints. The 510(k) number is K934468.

When did SLIP-ON FIXATION SPLINT (SFS) receive FDA 510(k) clearance?

SLIP-ON FIXATION SPLINT (SFS) received FDA 510(k) clearance on 1994-08-05, under 510(k) number K934468.

Who is the listed applicant for SLIP-ON FIXATION SPLINT (SFS)?

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

What is the FDA product code for SLIP-ON FIXATION SPLINT (SFS)?

The FDA product code for SLIP-ON FIXATION SPLINT (SFS) is EHO.

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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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