DeviceClearance

POLY REJUV— 510(k) K180875

Substantially Equivalent

Medtek Skincare, LLC

FDA 510(k) clearance K180875 for POLY REJUV, Substantially Equivalent on 2018-09-14. Applicant: Medtek Skincare, LLC. Device class: 2.

Clearance details

Applicant
Medtek Skincare, LLC
Product code
Code OHS
Device class
Class 2
Regulation
21 CFR 878.4810
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hudson, NY, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code OHS

product code OHS
Other
1
Total
1

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.