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FDA 510(k)

SUR-FIT FLEXIBLE

K-Number: K830945 · 1983-04-12

ApplicantConvatec, A Division of E.R. Squibb & Sons
Decision Date1983-04-12
Product CodeEXB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SUR-FIT FLEXIBLE is the device name listed in this FDA 510(k) record. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. It received FDA 510(k) clearance on 1983-04-12 under 510(k) number K830945. The device is classified under product code EXB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUR-FIT FLEXIBLE?

SUR-FIT FLEXIBLE is a medical device that received FDA 510(k) clearance on 1983-04-12. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. The 510(k) number is K830945.

When did SUR-FIT FLEXIBLE receive FDA 510(k) clearance?

SUR-FIT FLEXIBLE received FDA 510(k) clearance on 1983-04-12, under 510(k) number K830945.

Who is the listed applicant for SUR-FIT FLEXIBLE?

The FDA 510(k) record lists Convatec, A Division of E.R. Squibb & Sons as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUR-FIT FLEXIBLE?

The FDA product code for SUR-FIT FLEXIBLE is EXB.

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Other records listing Convatec, A Division of E.R. Squibb & Sons as applicant

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Related Devices (Code: EXB)

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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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