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FDA 510(k)

MEC BUTRESS PLATE

K-Number: K850444 · 1985-04-19

ApplicantPfizer, Inc.
Decision Date1985-04-19
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MEC BUTRESS PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Pfizer, Inc.. It received FDA 510(k) clearance on 1985-04-19 under 510(k) number K850444. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEC BUTRESS PLATE?

MEC BUTRESS PLATE is a medical device that received FDA 510(k) clearance on 1985-04-19. The listed applicant is Pfizer, Inc.. The 510(k) number is K850444.

When did MEC BUTRESS PLATE receive FDA 510(k) clearance?

MEC BUTRESS PLATE received FDA 510(k) clearance on 1985-04-19, under 510(k) number K850444.

Who is the listed applicant for MEC BUTRESS PLATE?

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

What is the FDA product code for MEC BUTRESS PLATE?

The FDA product code for MEC BUTRESS PLATE is HRS.

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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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