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FDA 510(k)

CR-39 TYPE RESIN

K-Number: K850905 · 1985-03-20

ApplicantOrplex Corp.
Decision Date1985-03-20
Product CodeHQG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CR-39 TYPE RESIN is the device name listed in this FDA 510(k) record. The listed applicant is Orplex Corp.. It received FDA 510(k) clearance on 1985-03-20 under 510(k) number K850905. The device is classified under product code HQG. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CR-39 TYPE RESIN?

CR-39 TYPE RESIN is a medical device that received FDA 510(k) clearance on 1985-03-20. The listed applicant is Orplex Corp.. The 510(k) number is K850905.

When did CR-39 TYPE RESIN receive FDA 510(k) clearance?

CR-39 TYPE RESIN received FDA 510(k) clearance on 1985-03-20, under 510(k) number K850905.

Who is the listed applicant for CR-39 TYPE RESIN?

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

What is the FDA product code for CR-39 TYPE RESIN?

The FDA product code for CR-39 TYPE RESIN is HQG.

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Related Devices (Code: HQG)

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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