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FDA 510(k)

EXTERNAL MECHANICAL FASTENER

K-Number: K854068 · 1985-11-22

ApplicantWells Johnson Co.
Decision Date1985-11-22
Product Code
DecisionSubstantially Equivalent

Device Summary

EXTERNAL MECHANICAL FASTENER is the device name listed in this FDA 510(k) record. The listed applicant is Wells Johnson Co.. It received FDA 510(k) clearance on 1985-11-22 under 510(k) number K854068. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTERNAL MECHANICAL FASTENER?

EXTERNAL MECHANICAL FASTENER is a medical device that received FDA 510(k) clearance on 1985-11-22. The listed applicant is Wells Johnson Co.. The 510(k) number is K854068.

When did EXTERNAL MECHANICAL FASTENER receive FDA 510(k) clearance?

EXTERNAL MECHANICAL FASTENER received FDA 510(k) clearance on 1985-11-22, under 510(k) number K854068.

Who is the listed applicant for EXTERNAL MECHANICAL FASTENER?

The FDA 510(k) record lists Wells Johnson Co. as the applicant. This does not by itself establish the device manufacturer.

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Other records listing Wells Johnson Co. 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.

K991437WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00K984448BIRCOLL BALLOON DISSECTORK971580UAS ULTRASONIC ASPIRATOR SYSTEMK945876WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHTK945500WELLS JOHNSON FIXATION SYSTEMK951519WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT

View all 15 devices →

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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