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FDA 510(k)

TRIMLINE 2000

K-Number: K943081 · 1995-01-27

ApplicantPymah Corp.
Decision Date1995-01-27
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRIMLINE 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Pymah Corp.. It received FDA 510(k) clearance on 1995-01-27 under 510(k) number K943081. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIMLINE 2000?

TRIMLINE 2000 is a medical device that received FDA 510(k) clearance on 1995-01-27. The listed applicant is Pymah Corp.. The 510(k) number is K943081.

When did TRIMLINE 2000 receive FDA 510(k) clearance?

TRIMLINE 2000 received FDA 510(k) clearance on 1995-01-27, under 510(k) number K943081.

Who is the listed applicant for TRIMLINE 2000?

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

What is the FDA product code for TRIMLINE 2000?

The FDA product code for TRIMLINE 2000 is DXN.

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Other records listing Pymah Corp. as applicant

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Related Devices (Code: DXN)

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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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