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FDA 510(k)

DECALCIFYING SOLUTION

K-Number: K872625 · 1987-08-06

ApplicantStephens Scientific
Decision Date1987-08-06
Product CodeKDX
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

DECALCIFYING SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Stephens Scientific. It received FDA 510(k) clearance on 1987-08-06 under 510(k) number K872625. 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 DECALCIFYING SOLUTION?

DECALCIFYING SOLUTION is a medical device that received FDA 510(k) clearance on 1987-08-06. The listed applicant is Stephens Scientific. The 510(k) number is K872625.

When did DECALCIFYING SOLUTION receive FDA 510(k) clearance?

DECALCIFYING SOLUTION received FDA 510(k) clearance on 1987-08-06, under 510(k) number K872625.

Who is the listed applicant for DECALCIFYING SOLUTION?

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

What is the FDA product code for DECALCIFYING SOLUTION?

The FDA product code for DECALCIFYING SOLUTION is KDX.

Related Clinical Trials

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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Other records listing Stephens Scientific 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.

K893772TISSUE EMBEDDING MEDIUMK881359DECALCIFYING SOLUTION IIK832011AMERI CLEAR

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.

K850636SIMUTANEOUS 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.K811801CAL-RITERichard-Allan Medical Ind., Inc.

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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