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FDA 510(k)

BARTELS EXTRACELLULAR MATRIX

K-Number: K902726 · 1990-09-24

ApplicantBaxter Healthcare Corp
Decision Date1990-09-24
Product CodeKIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BARTELS EXTRACELLULAR MATRIX is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1990-09-24 under 510(k) number K902726. The device is classified under product code KIR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARTELS EXTRACELLULAR MATRIX?

BARTELS EXTRACELLULAR MATRIX is a medical device that received FDA 510(k) clearance on 1990-09-24. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K902726.

When did BARTELS EXTRACELLULAR MATRIX receive FDA 510(k) clearance?

BARTELS EXTRACELLULAR MATRIX received FDA 510(k) clearance on 1990-09-24, under 510(k) number K902726.

Who is the listed applicant for BARTELS EXTRACELLULAR MATRIX?

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

What is the FDA product code for BARTELS EXTRACELLULAR MATRIX?

The FDA product code for BARTELS EXTRACELLULAR MATRIX is KIR.

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Other records listing Baxter Healthcare Corp as applicant

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Related Devices (Code: KIR)

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.

K973212FRESH CELLS WI-38Diagnostic Hybrids, Inc.K973210FRESH CELLS NCI H292Diagnostic Hybrids, Inc.K973209FRESH CELLS VERODiagnostic Hybrids, Inc.K973211FRESH CELLS MV1LUDiagnostic Hybrids, Inc.K973213FRESH CELLS LLC-MK2Diagnostic Hybrids, Inc.K973214FRESH CELLS HFFDiagnostic Hybrids, 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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