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FDA 510(k)

FALKON STRETCH-STERILE

K-Number: K854850 · 1986-01-13

ApplicantG.B.F. Industries, Inc.
Decision Date1986-01-13
Product CodeNAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FALKON STRETCH-STERILE is the device name listed in this FDA 510(k) record. The listed applicant is G.B.F. Industries, Inc.. It received FDA 510(k) clearance on 1986-01-13 under 510(k) number K854850. The device is classified under product code NAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FALKON STRETCH-STERILE?

FALKON STRETCH-STERILE is a medical device that received FDA 510(k) clearance on 1986-01-13. The listed applicant is G.B.F. Industries, Inc.. The 510(k) number is K854850.

When did FALKON STRETCH-STERILE receive FDA 510(k) clearance?

FALKON STRETCH-STERILE received FDA 510(k) clearance on 1986-01-13, under 510(k) number K854850.

Who is the listed applicant for FALKON STRETCH-STERILE?

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

What is the FDA product code for FALKON STRETCH-STERILE?

The FDA product code for FALKON STRETCH-STERILE is NAD.

Related Clinical Trials

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Other records listing G.B.F. Industries, Inc. as applicant

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.

K862565CHEMTROL(TM)K862587CHEMTROL(TM)K862586CHEMVARION(TM)K854432FALKON STRETCH

Related Devices (Code: NAD)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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