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FDA 510(k)

DECALCIFIER I

K-Number: K841488 · 1984-05-02

ApplicantSurgipath Medical Industries, Inc.
Decision Date1984-05-02
Product CodeKDX
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

DECALCIFIER I is the device name listed in this FDA 510(k) record. The listed applicant is Surgipath Medical Industries, Inc.. It received FDA 510(k) clearance on 1984-05-02 under 510(k) number K841488. 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 I?

DECALCIFIER I is a medical device that received FDA 510(k) clearance on 1984-05-02. The listed applicant is Surgipath Medical Industries, Inc.. The 510(k) number is K841488.

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

DECALCIFIER I received FDA 510(k) clearance on 1984-05-02, under 510(k) number K841488.

Who is the listed applicant for DECALCIFIER I?

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

What is the FDA product code for DECALCIFIER I?

The FDA product code for DECALCIFIER I is KDX.

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Other records listing Surgipath Medical Industries, 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.

K883217SCHIFF REAGENTK881921C-E BRUSHK881922CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVEK881659TISSUE SECTION ADHESIVEK863549REUSABLE/DISPOSABLE AUTOPSY KNIFE SETK863616KNIFE MAKER

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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.K822036VOLU-SOL DECALCIFERVolu Sol Medical IndustriesK821443FORMICALLerner Laboratories, Inc.K811801CAL-RITERichard-Allan Medical Ind., 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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