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FDA 510(k)

SURFLEX F

K-Number: K844329 · 1984-12-03

ApplicantG-C Intl. Corp.
Decision Date1984-12-03
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SURFLEX F is the device name listed in this FDA 510(k) record. The listed applicant is G-C Intl. Corp.. It received FDA 510(k) clearance on 1984-12-03 under 510(k) number K844329. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURFLEX F?

SURFLEX F is a medical device that received FDA 510(k) clearance on 1984-12-03. The listed applicant is G-C Intl. Corp.. The 510(k) number is K844329.

When did SURFLEX F receive FDA 510(k) clearance?

SURFLEX F received FDA 510(k) clearance on 1984-12-03, under 510(k) number K844329.

Who is the listed applicant for SURFLEX F?

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

What is the FDA product code for SURFLEX F?

The FDA product code for SURFLEX F is ELW.

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Other records listing G-C Intl. Corp. as applicant

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Related Devices (Code: ELW)

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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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