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FDA 510(k)

P POLYMER

K-Number: K893990 · 1989-10-12

ApplicantPace West
Decision Date1989-10-12
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

P POLYMER is the device name listed in this FDA 510(k) record. The listed applicant is Pace West. It received FDA 510(k) clearance on 1989-10-12 under 510(k) number K893990. The device is classified under product code LDD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P POLYMER?

P POLYMER is a medical device that received FDA 510(k) clearance on 1989-10-12. The listed applicant is Pace West. The 510(k) number is K893990.

When did P POLYMER receive FDA 510(k) clearance?

P POLYMER received FDA 510(k) clearance on 1989-10-12, under 510(k) number K893990.

Who is the listed applicant for P POLYMER?

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

What is the FDA product code for P POLYMER?

The FDA product code for P POLYMER is LDD.

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.

Related Devices (Code: LDD)

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.

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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