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FDA 510(k)

HEEL OR ELBOW PROTECTOR

K-Number: K812344 · 1981-09-11

ApplicantFred Sammons, Inc.
Decision Date1981-09-11
Product CodeFMP
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HEEL OR ELBOW PROTECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Fred Sammons, Inc.. It received FDA 510(k) clearance on 1981-09-11 under 510(k) number K812344. The device is classified under product code FMP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEEL OR ELBOW PROTECTOR?

HEEL OR ELBOW PROTECTOR is a medical device that received FDA 510(k) clearance on 1981-09-11. The listed applicant is Fred Sammons, Inc.. The 510(k) number is K812344.

When did HEEL OR ELBOW PROTECTOR receive FDA 510(k) clearance?

HEEL OR ELBOW PROTECTOR received FDA 510(k) clearance on 1981-09-11, under 510(k) number K812344.

Who is the listed applicant for HEEL OR ELBOW PROTECTOR?

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

What is the FDA product code for HEEL OR ELBOW PROTECTOR?

The FDA product code for HEEL OR ELBOW PROTECTOR is FMP.

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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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