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FDA 510(k)

POLYPOLE

K-Number: K861838 · 1986-06-09

ApplicantPoly Medical Technologies, Inc.
Decision Date1986-06-09
Product CodeFOX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POLYPOLE is the device name listed in this FDA 510(k) record. The listed applicant is Poly Medical Technologies, Inc.. It received FDA 510(k) clearance on 1986-06-09 under 510(k) number K861838. The device is classified under product code FOX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYPOLE?

POLYPOLE is a medical device that received FDA 510(k) clearance on 1986-06-09. The listed applicant is Poly Medical Technologies, Inc.. The 510(k) number is K861838.

When did POLYPOLE receive FDA 510(k) clearance?

POLYPOLE received FDA 510(k) clearance on 1986-06-09, under 510(k) number K861838.

Who is the listed applicant for POLYPOLE?

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

What is the FDA product code for POLYPOLE?

The FDA product code for POLYPOLE is FOX.

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Related Devices (Code: FOX)

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.

K980336IV STANDSClinton Industries, Inc.K964782MEDRAD CONTRAST HOLDERMedrad, Inc.K961470PORT-A-POLEPrins Medical Ind., Inc.K960027HIGH VOLUME I.V. & IRRIGATION TOWERAllen Medical Systems, Inc.K952196IV POLE/STANDValentine Intl. , Ltd.K950367IV SHUTTLEEquipment Concepts, 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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