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FDA 510(k)

POLYURETHANE SOLUTION 29% W/W

K-Number: K944934 · 1994-12-09

ApplicantKnowell Therapeutic Technologies,Inc.
Decision Date1994-12-09
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

POLYURETHANE SOLUTION 29% W/W is the device name listed in this FDA 510(k) record. The listed applicant is Knowell Therapeutic Technologies,Inc.. It received FDA 510(k) clearance on 1994-12-09 under 510(k) number K944934. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYURETHANE SOLUTION 29% W/W?

POLYURETHANE SOLUTION 29% W/W is a medical device that received FDA 510(k) clearance on 1994-12-09. The listed applicant is Knowell Therapeutic Technologies,Inc.. The 510(k) number is K944934.

When did POLYURETHANE SOLUTION 29% W/W receive FDA 510(k) clearance?

POLYURETHANE SOLUTION 29% W/W received FDA 510(k) clearance on 1994-12-09, under 510(k) number K944934.

Who is the listed applicant for POLYURETHANE SOLUTION 29% W/W?

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

What is the FDA product code for POLYURETHANE SOLUTION 29% W/W?

The FDA product code for POLYURETHANE SOLUTION 29% W/W is LBH.

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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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