The following data is part of a premarket notification filed by Ttk Healthcare Limited with the FDA for Skore Smooth Condoms - Skore Colors & Flavors, Skore Smooth Condoms - Skore Vanilla.
Device ID | K213547 |
510k Number | K213547 |
Device Name: | SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla |
Classification | Condom |
Applicant | TTK Healthcare Limited 12, K P Natham Road, Thiruvandar Koil, Puducherry, IN 605102 |
Contact | Daniel J S |
Correspondent | Daniel J S TTK Healthcare Limited 6, Cathedral Road Chennai, IN 600086 |
Product Code | HIS |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-11-08 |
Decision Date | 2021-12-23 |