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FDA 510(k)

PLASTI-PORE SEPTAL BUTTON

K-Number: K781574 · 1978-09-27

ApplicantRichard'S Medical Equip., Inc.
Decision Date1978-09-27
Product CodeFZE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PLASTI-PORE SEPTAL BUTTON is the device name listed in this FDA 510(k) record. The listed applicant is Richard'S Medical Equip., Inc.. It received FDA 510(k) clearance on 1978-09-27 under 510(k) number K781574. The device is classified under product code FZE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLASTI-PORE SEPTAL BUTTON?

PLASTI-PORE SEPTAL BUTTON is a medical device that received FDA 510(k) clearance on 1978-09-27. The listed applicant is Richard'S Medical Equip., Inc.. The 510(k) number is K781574.

When did PLASTI-PORE SEPTAL BUTTON receive FDA 510(k) clearance?

PLASTI-PORE SEPTAL BUTTON received FDA 510(k) clearance on 1978-09-27, under 510(k) number K781574.

Who is the listed applicant for PLASTI-PORE SEPTAL BUTTON?

The FDA 510(k) record lists Richard'S Medical Equip., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLASTI-PORE SEPTAL BUTTON?

The FDA product code for PLASTI-PORE SEPTAL BUTTON is FZE.

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Related Devices (Code: FZE)

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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.

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