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FDA 510(k)

POLYTITER SYSTEM

K-Number: K012163 · 2001-08-20

ApplicantPolymedco, Inc.
Decision Date2001-08-20
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

POLYTITER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Polymedco, Inc.. It received FDA 510(k) clearance on 2001-08-20 under 510(k) number K012163. The device is classified under product code DHN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYTITER SYSTEM?

POLYTITER SYSTEM is a medical device that received FDA 510(k) clearance on 2001-08-20. The listed applicant is Polymedco, Inc.. The 510(k) number is K012163.

When did POLYTITER SYSTEM receive FDA 510(k) clearance?

POLYTITER SYSTEM received FDA 510(k) clearance on 2001-08-20, under 510(k) number K012163.

Who is the listed applicant for POLYTITER SYSTEM?

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 POLYTITER SYSTEM?

The FDA product code for POLYTITER SYSTEM is DHN.

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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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