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FDA 510(k)

ORANGE G-6

K-Number: K811825 · 1981-07-10

ApplicantSurgipath
Decision Date1981-07-10
Product CodeHZH
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ORANGE G-6 is the device name listed in this FDA 510(k) record. The listed applicant is Surgipath. It received FDA 510(k) clearance on 1981-07-10 under 510(k) number K811825. The device is classified under product code HZH. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORANGE G-6?

ORANGE G-6 is a medical device that received FDA 510(k) clearance on 1981-07-10. The listed applicant is Surgipath. The 510(k) number is K811825.

When did ORANGE G-6 receive FDA 510(k) clearance?

ORANGE G-6 received FDA 510(k) clearance on 1981-07-10, under 510(k) number K811825.

Who is the listed applicant for ORANGE G-6?

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

What is the FDA product code for ORANGE G-6?

The FDA product code for ORANGE G-6 is HZH.

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Other records listing Surgipath 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.

K820027MODIFIED EA 50K81294010% NEUTRAL BUFFERED FORMALIN CONCENTK812086EA 65K812087EA 50K811826EOSIN YK810836DECALCIFIER II

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Related Devices (Code: HZH)

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.

K842924ORANGE G, 1%E K Ind., Inc.K822038VOLU-SOL ORANGE G-6(GILLS-MODVolu Sol Medical IndustriesK800323VOLU-SOL ORANGE G-6 STAINVolu Sol Medical Industries

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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