FDA 510(k)

CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER

K-Number: K990083 · 1999-02-12

Decision Date1999-02-12

Product CodeFPA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER is the device name listed in this FDA 510(k) record. The listed applicant is Sims Deltec, Inc.. It received FDA 510(k) clearance on 1999-02-12 under 510(k) number K990083. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER?

CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER is a medical device that received FDA 510(k) clearance on 1999-02-12. The listed applicant is Sims Deltec, Inc.. The 510(k) number is K990083.

When did CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER receive FDA 510(k) clearance?

CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER received FDA 510(k) clearance on 1999-02-12, under 510(k) number K990083.

Who is the listed applicant for CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER?

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

What is the FDA product code for CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER?

The FDA product code for CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER is FPA.

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Other records listing Sims Deltec, Inc. as applicant

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Related Devices (Code: FPA)

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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.