Cleared Traditional

SKORE (Colors & Flavors), SKORE (Colors)

K202403 · Ttk Healthcare Limited · Obstetrics & Gynecology
Apr 2021
Decision
237d
Days
Class 2
Risk

About This 510(k) Submission

K202403 is an FDA 510(k) clearance for the SKORE (Colors & Flavors), SKORE (Colors), a Condom (Class II — Special Controls, product code HIS), submitted by Ttk Healthcare Limited (Puducherry, IN). The FDA issued a Cleared decision on April 15, 2021, 237 days after receiving the submission on August 21, 2020. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number K202403 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2020
Decision Date April 15, 2021
Days to Decision 237 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HIS — Condom
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5300

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