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FDA 510(k)

LATEX, IN-HOUSE COMPOUNDED

K-Number: K781847 · 1978-11-03

ApplicantArbrook Mfg. Corp.
Decision Date1978-11-03
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LATEX, IN-HOUSE COMPOUNDED is the device name listed in this FDA 510(k) record. The listed applicant is Arbrook Mfg. Corp.. It received FDA 510(k) clearance on 1978-11-03 under 510(k) number K781847. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LATEX, IN-HOUSE COMPOUNDED?

LATEX, IN-HOUSE COMPOUNDED is a medical device that received FDA 510(k) clearance on 1978-11-03. The listed applicant is Arbrook Mfg. Corp.. The 510(k) number is K781847.

When did LATEX, IN-HOUSE COMPOUNDED receive FDA 510(k) clearance?

LATEX, IN-HOUSE COMPOUNDED received FDA 510(k) clearance on 1978-11-03, under 510(k) number K781847.

Who is the listed applicant for LATEX, IN-HOUSE COMPOUNDED?

The FDA 510(k) record lists Arbrook Mfg. Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LATEX, IN-HOUSE COMPOUNDED?

The FDA product code for LATEX, IN-HOUSE COMPOUNDED is KGO.

Related Clinical Trials

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Other records listing Arbrook Mfg. Corp. 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.

K792016DISCARD-A-PAD 40-COUNT SHARPS DISPOSALK781278GLOVES, PROCEDUREK770056GLOVES, SURGEONS,MICRO-TOUCH POWDERFREEK760421THERMOMETER, SURVALENT-ELECTRONIC

Related Devices (Code: KGO)

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

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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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