The following data is part of a premarket notification filed by Ttk Healthcare Limited with the FDA for Skore (colors & Flavors), Skore (colors).
| Device ID | K202403 |
| 510k Number | K202403 |
| Device Name: | SKORE (Colors & Flavors), SKORE (Colors) |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-21 |
| Decision Date | 2021-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08906007134965 | K202403 | 000 |
| 08906007135047 | K202403 | 000 |
| 08906007135085 | K202403 | 000 |
| 08906007135122 | K202403 | 000 |
| 08906007134712 | K202403 | 000 |
| 08906007134767 | K202403 | 000 |
| 08906007134804 | K202403 | 000 |
| 08906007134842 | K202403 | 000 |
| 08906007134880 | K202403 | 000 |
| 08906007134927 | K202403 | 000 |
| 08906007135009 | K202403 | 000 |