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FDA 510(k)

COATED NOVAFIL, POLYBUTESTER, MESH

K-Number: K896946 · 1990-05-07

ApplicantAmerican Cyanamid Co.
Decision Date1990-05-07
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COATED NOVAFIL, POLYBUTESTER, MESH is the device name listed in this FDA 510(k) record. The listed applicant is American Cyanamid Co.. It received FDA 510(k) clearance on 1990-05-07 under 510(k) number K896946. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COATED NOVAFIL, POLYBUTESTER, MESH?

COATED NOVAFIL, POLYBUTESTER, MESH is a medical device that received FDA 510(k) clearance on 1990-05-07. The listed applicant is American Cyanamid Co.. The 510(k) number is K896946.

When did COATED NOVAFIL, POLYBUTESTER, MESH receive FDA 510(k) clearance?

COATED NOVAFIL, POLYBUTESTER, MESH received FDA 510(k) clearance on 1990-05-07, under 510(k) number K896946.

Who is the listed applicant for COATED NOVAFIL, POLYBUTESTER, MESH?

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

What is the FDA product code for COATED NOVAFIL, POLYBUTESTER, MESH?

The FDA product code for COATED NOVAFIL, POLYBUTESTER, MESH is FTM.

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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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