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FDA 510(k)

FIRM MASTER

K-Number: K905195 · 1991-02-01

ApplicantBak Medical Products
Decision Date1991-02-01
Product CodeLKY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FIRM MASTER is the device name listed in this FDA 510(k) record. The listed applicant is Bak Medical Products. It received FDA 510(k) clearance on 1991-02-01 under 510(k) number K905195. The device is classified under product code LKY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIRM MASTER?

FIRM MASTER is a medical device that received FDA 510(k) clearance on 1991-02-01. The listed applicant is Bak Medical Products. The 510(k) number is K905195.

When did FIRM MASTER receive FDA 510(k) clearance?

FIRM MASTER received FDA 510(k) clearance on 1991-02-01, under 510(k) number K905195.

Who is the listed applicant for FIRM MASTER?

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

What is the FDA product code for FIRM MASTER?

The FDA product code for FIRM MASTER is LKY.

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Related Devices (Code: LKY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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