FDA 510(k)

HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU

K-Number: K990913 · 1999-06-08

Decision Date1999-06-08

Product CodeMQE

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU is the device name listed in this FDA 510(k) record. The listed applicant is Laboratoires Prodimed. It received FDA 510(k) clearance on 1999-06-08 under 510(k) number K990913. The device is classified under product code MQE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU?

HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU is a medical device that received FDA 510(k) clearance on 1999-06-08. The listed applicant is Laboratoires Prodimed. The 510(k) number is K990913.

When did HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU receive FDA 510(k) clearance?

HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU received FDA 510(k) clearance on 1999-06-08, under 510(k) number K990913.

Who is the listed applicant for HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU?

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

What is the FDA product code for HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU?

The FDA product code for HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU is MQE.

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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.