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510(k) K202403

SKORE (Colors & Flavors), SKORE (Colors) by Ttk Healthcare Limited — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2021
Date Received
August 21, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condom
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type

Other clearances by Ttk Healthcare Limited

  • K230049 — SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE (September 7, 2023)
  • K213547 — SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vani (December 23, 2021)

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