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FDA 510(k)

DECALCIFIER II

K-Number: K810836 · 1981-04-23

ApplicantSurgipath
Decision Date1981-04-23
Product CodeKDX
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

DECALCIFIER II is the device name listed in this FDA 510(k) record. The listed applicant is Surgipath. It received FDA 510(k) clearance on 1981-04-23 under 510(k) number K810836. The device is classified under product code KDX. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DECALCIFIER II?

DECALCIFIER II is a medical device that received FDA 510(k) clearance on 1981-04-23. The listed applicant is Surgipath. The 510(k) number is K810836.

When did DECALCIFIER II receive FDA 510(k) clearance?

DECALCIFIER II received FDA 510(k) clearance on 1981-04-23, under 510(k) number K810836.

Who is the listed applicant for DECALCIFIER II?

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 DECALCIFIER II?

The FDA product code for DECALCIFIER II is KDX.

Related Clinical Trials

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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 50K811825ORANGE G-6K811826EOSIN Y

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Related Devices (Code: KDX)

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.

K872625DECALCIFYING SOLUTIONStephens ScientificK850636SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-EFisher Scientific Co., LLCK842726DECALCIFIER SOLUTIONE K Ind., Inc.K841488DECALCIFIER ISurgipath Medical Industries, Inc.K822036VOLU-SOL DECALCIFERVolu Sol Medical IndustriesK821443FORMICALLerner 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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