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FDA 510(k)

XYLENE

K-Number: K812847 · 1981-10-29

ApplicantRichard-Allan Medical Ind., Inc.
Decision Date1981-10-29
Product CodeKEM
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

XYLENE is the device name listed in this FDA 510(k) record. The listed applicant is Richard-Allan Medical Ind., Inc.. It received FDA 510(k) clearance on 1981-10-29 under 510(k) number K812847. The device is classified under product code KEM. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XYLENE?

XYLENE is a medical device that received FDA 510(k) clearance on 1981-10-29. The listed applicant is Richard-Allan Medical Ind., Inc.. The 510(k) number is K812847.

When did XYLENE receive FDA 510(k) clearance?

XYLENE received FDA 510(k) clearance on 1981-10-29, under 510(k) number K812847.

Who is the listed applicant for XYLENE?

The FDA 510(k) record lists Richard-Allan Medical Ind., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XYLENE?

The FDA product code for XYLENE is KEM.

Related Clinical Trials

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Other records listing Richard-Allan Medical Ind., 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.

K931879REFLEX HTRK924200REFLEX(R) ESCK926297REFLEX ESIK924761STERILE ENDOSCOPIC DISPOS TROCARS W/SAFE SHIELDK900566RICHARD-ALLAN VESSEL LOOPSK896262TITANIUM LIGATING CLIPS

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Related Devices (Code: KEM)

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.

K881282XYLENEAnatech, Ltd.K874461HEMO-SOLChem Pharm, Inc.K861490PERMACLEAR SOLUTION CAT. NO. 4950Helena LaboratoriesK855109CLEARENE, CLEARING AGENTSurgipath Medical Industries, Inc.K854083XYLENE SUBSTITUTE MONTANTLerner Laboratories, Inc.K853694XYLENE SUBSTITUTELerner Laboratories, Inc.

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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