FDA 510(k)

UNIVERSAL TRIAL FRAMEE

K-Number: K821084 · 1982-06-14

ApplicantMedical Equipment Designs, Inc.

Decision Date1982-06-14

Product CodeHPA

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

UNIVERSAL TRIAL FRAMEE is the device name listed in this FDA 510(k) record. The listed applicant is Medical Equipment Designs, Inc.. It received FDA 510(k) clearance on 1982-06-14 under 510(k) number K821084. The device is classified under product code HPA. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVERSAL TRIAL FRAMEE?

UNIVERSAL TRIAL FRAMEE is a medical device that received FDA 510(k) clearance on 1982-06-14. The listed applicant is Medical Equipment Designs, Inc.. The 510(k) number is K821084.

When did UNIVERSAL TRIAL FRAMEE receive FDA 510(k) clearance?

UNIVERSAL TRIAL FRAMEE received FDA 510(k) clearance on 1982-06-14, under 510(k) number K821084.

Who is the listed applicant for UNIVERSAL TRIAL FRAMEE?

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

What is the FDA product code for UNIVERSAL TRIAL FRAMEE?

The FDA product code for UNIVERSAL TRIAL FRAMEE is HPA.

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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.