FDA 510(k)

CEPTI-SEAL DRESSING CHANGE KIT FOR CENT VEN CATH

K-Number: K914316 · 1991-12-24

ApplicantMedi-Flex Hospital Products, Inc.

Decision Date1991-12-24

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent for Some Indications

Device Summary

CEPTI-SEAL DRESSING CHANGE KIT FOR CENT VEN CATH is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Flex Hospital Products, Inc.. It received FDA 510(k) clearance on 1991-12-24 under 510(k) number K914316. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the CEPTI-SEAL DRESSING CHANGE KIT FOR CENT VEN CATH?

CEPTI-SEAL DRESSING CHANGE KIT FOR CENT VEN CATH is a medical device that received FDA 510(k) clearance on 1991-12-24. The listed applicant is Medi-Flex Hospital Products, Inc.. The 510(k) number is K914316.

When did CEPTI-SEAL DRESSING CHANGE KIT FOR CENT VEN CATH receive FDA 510(k) clearance?

CEPTI-SEAL DRESSING CHANGE KIT FOR CENT VEN CATH received FDA 510(k) clearance on 1991-12-24, under 510(k) number K914316.

Who is the listed applicant for CEPTI-SEAL DRESSING CHANGE KIT FOR CENT VEN CATH?

The FDA 510(k) record lists Medi-Flex Hospital Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CEPTI-SEAL DRESSING CHANGE KIT FOR CENT VEN CATH?

The FDA product code for CEPTI-SEAL DRESSING CHANGE KIT FOR CENT VEN CATH is LYY.

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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.