SKORE (Colors & Flavors), SKORE (Colors)— 510(k) K202403

Name: FDA 510(k) clearance K202403
Creator: U.S. Food and Drug Administration
Published: 2021-04-15

Substantially Equivalent

Ttk Healthcare Limited

FDA 510(k) clearance K202403 for SKORE (Colors & Flavors), SKORE (Colors), Substantially Equivalent on 2021-04-15. Applicant: Ttk Healthcare Limited. Device class: 2.

Clearance details

Applicant: Ttk Healthcare Limited
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2020-08-21
Decision date: 2021-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Puducherry, IN

Download summary PDF View on FDA.gov ↗

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