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FDA 510(k)

CLEAR-RITE II

K-Number: K812846 · 1981-10-29

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

Device Summary

CLEAR-RITE II 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 K812846. 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 CLEAR-RITE II?

CLEAR-RITE II 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 K812846.

When did CLEAR-RITE II receive FDA 510(k) clearance?

CLEAR-RITE II received FDA 510(k) clearance on 1981-10-29, under 510(k) number K812846.

Who is the listed applicant for CLEAR-RITE II?

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 CLEAR-RITE II?

The FDA product code for CLEAR-RITE II is KEM.

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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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