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510(k) K052870

Device
INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200
Applicant
KIMBERLY-CLARK CORP.
510(k) number
K052870
Product code
NZP  
Decision
Substantially Equivalent (SESE)
Decision date
2006-09-29
Date received
2005-10-11
Regulation
878.4370
Classification name
Sealant, Microbial
Medical specialty
General & Plastic Surgery
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
TIERNEY NORSTED
Address
5353 Wayzata Blvd. Suite 505 Minneapolis MN US 55416 55416

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NZP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K223669SecurePortIV Advanced Catheter Securement AdhesiveAdhezion Biomedical, LLC2023-06-12
K170505SecurePortIV Catheter Securement AdhesiveAdhezion Biomedical, LLC2017-09-29
K083354FLORASEAL, MODEL FS350DAdhezion Biomedical2009-07-20

Legacy Summary#

summary

FDA Review#

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