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FDA 510(k)

FIX-RIGHT 90ML & 180 ML PREFILLED CONT

K-Number: K811793 · 1981-07-31

ApplicantRichard-Allan Medical Ind., Inc.
Decision Date1981-07-31
Product CodeKDT
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

FIX-RIGHT 90ML & 180 ML PREFILLED CONT 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 1981-07-31 under 510(k) number K811793. The device is classified under product code KDT. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIX-RIGHT 90ML & 180 ML PREFILLED CONT?

FIX-RIGHT 90ML & 180 ML PREFILLED CONT is a medical device that received FDA 510(k) clearance on 1981-07-31. The listed applicant is Richard-Allan Medical Ind., Inc.. The 510(k) number is K811793.

When did FIX-RIGHT 90ML & 180 ML PREFILLED CONT receive FDA 510(k) clearance?

FIX-RIGHT 90ML & 180 ML PREFILLED CONT received FDA 510(k) clearance on 1981-07-31, under 510(k) number K811793.

Who is the listed applicant for FIX-RIGHT 90ML & 180 ML PREFILLED CONT?

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 FIX-RIGHT 90ML & 180 ML PREFILLED CONT?

The FDA product code for FIX-RIGHT 90ML & 180 ML PREFILLED CONT is KDT.

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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: KDT)

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.

K873593BIOSURE SPECIMEN COLLECTION CONTAINERBiosure, Inc.K862665NOVACYTE-UXsirius Medical, Inc.K834579BIOSPAL 2400SHospal Medical Corp.K834412PRESERV PVA FIXATIVE 15ML-FORMALIN PKPreventive Diagnostics Corp.K833660PRESERV PVA FIXATIVE -MALIN PACKPreventive Diagnostics Corp.K823773PROVIAL II #006-010-0201Dynatech Corp.

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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