TRINITY WRINKLE REMOVER— 510(k) K120560

Substantially Equivalent

Carol Cole Company

FDA 510(k) clearance K120560 for TRINITY WRINKLE REMOVER, Substantially Equivalent on 2012-11-06. Applicant: Carol Cole Company. Device class: 2.

Clearance details

Applicant
Carol Cole Company
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
Poway, CA, US
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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.