PERIOPATCH— 510(k) K110750

Substantially Equivalent

Mis Implants Technologies , Ltd.

FDA 510(k) clearance K110750 for PERIOPATCH, Substantially Equivalent on 2011-04-28. Applicant: Mis Implants Technologies , Ltd.. Device class: Unclassified.

Clearance details

Applicant
Mis Implants Technologies , Ltd.
Product code
Code OLR
Device class
Unclassified
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bar Lev Industrial Park, IL
Download summary PDFView on FDA.gov ↗

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Adverse events under product code OLR

product code OLR
Death
3
Total
3

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.