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FDA 510(k)

INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200

K-Number: K052870 · 2006-09-29

ApplicantKimberly-Clark Corp.
Decision Date2006-09-29
Product CodeNZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200 is the device name listed in this FDA 510(k) record. The listed applicant is Kimberly-Clark Corp.. It received FDA 510(k) clearance on 2006-09-29 under 510(k) number K052870. The device is classified under product code NZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200?

INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200 is a medical device that received FDA 510(k) clearance on 2006-09-29. The listed applicant is Kimberly-Clark Corp.. The 510(k) number is K052870.

When did INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200 receive FDA 510(k) clearance?

INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200 received FDA 510(k) clearance on 2006-09-29, under 510(k) number K052870.

Who is the listed applicant for INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200?

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

What is the FDA product code for INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200?

The FDA product code for INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200 is NZP.

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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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