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FDA 510(k)

POLY-CHEM 90 GLUCOSE

K-Number: K090703 · 2009-10-20

ApplicantPolymedco, Inc.
Decision Date2009-10-20
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

POLY-CHEM 90 GLUCOSE is the device name listed in this FDA 510(k) record. The listed applicant is Polymedco, Inc.. It received FDA 510(k) clearance on 2009-10-20 under 510(k) number K090703. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLY-CHEM 90 GLUCOSE?

POLY-CHEM 90 GLUCOSE is a medical device that received FDA 510(k) clearance on 2009-10-20. The listed applicant is Polymedco, Inc.. The 510(k) number is K090703.

When did POLY-CHEM 90 GLUCOSE receive FDA 510(k) clearance?

POLY-CHEM 90 GLUCOSE received FDA 510(k) clearance on 2009-10-20, under 510(k) number K090703.

Who is the listed applicant for POLY-CHEM 90 GLUCOSE?

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

What is the FDA product code for POLY-CHEM 90 GLUCOSE?

The FDA product code for POLY-CHEM 90 GLUCOSE is CFR.

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Other records listing Polymedco, 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.

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Related Devices (Code: CFR)

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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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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