FDA 510(k)

MYELOSTAT DORSAL CORD STIMULATOR, ETC.

K-Number: K801384 · 1980-07-08

Decision Date1980-07-08

Product CodeGZB

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MYELOSTAT DORSAL CORD STIMULATOR, ETC. is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1980-07-08 under 510(k) number K801384. The device is classified under product code GZB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYELOSTAT DORSAL CORD STIMULATOR, ETC.?

MYELOSTAT DORSAL CORD STIMULATOR, ETC. is a medical device that received FDA 510(k) clearance on 1980-07-08. The listed applicant is Medtronic Vascular. The 510(k) number is K801384.

When did MYELOSTAT DORSAL CORD STIMULATOR, ETC. receive FDA 510(k) clearance?

MYELOSTAT DORSAL CORD STIMULATOR, ETC. received FDA 510(k) clearance on 1980-07-08, under 510(k) number K801384.

Who is the listed applicant for MYELOSTAT DORSAL CORD STIMULATOR, ETC.?

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

What is the FDA product code for MYELOSTAT DORSAL CORD STIMULATOR, ETC.?

The FDA product code for MYELOSTAT DORSAL CORD STIMULATOR, ETC. is GZB.

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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.