Data / Medical devices / India / TTK Healthcare Limited - Protective Devices Division
TTK Healthcare Limited - Protective Devices Division: FDA-registered device maker in VIRUDHUNAGAR Tamil Nadu, India, 5 510(k) clearances
TTK Healthcare Limited - Protective Devices Division is registered with the FDA (registration 9680394) in VIRUDHUNAGAR Tamil Nadu, India. It lists 1 device type. The FDA files 5 510(k) clearances under its listings, the newest dated September 7, 2023. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 9680394
- FEI number
- 3005203207
- Address
- No. 20, 21, Perali Road, VIRUDHUNAGAR Tamil Nadu, India, 626001
- Owner or operator
- TTK Healthcare Limited (10086471)
- Roles
- Manufacturer
- First device listed
- November 11, 2022
- Registered through
- 2027
- Brand names listed
- SKORE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condom | HIS | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 7, 2023 | K230049 | SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT | HIS | Substantially Equivalent | Ttk Healthcare Limited | accessdata.fda.gov |
| December 23, 2021 | K213547 | SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla | HIS | Substantially Equivalent | Ttk Healthcare Limited | accessdata.fda.gov |
| April 15, 2021 | K202403 | SKORE (Colors & Flavors), SKORE (Colors) | HIS | Substantially Equivalent | Ttk Healthcare Limited | accessdata.fda.gov |
| October 20, 2014 | K132490 | SKORE AND MULTIPLE BRANDS | HIS | Substantially Equivalent | Ttk Protective Devices Limited (Formerly Ttk-Lig L | accessdata.fda.gov |
| May 1, 2014 | K131866 | SUSTAIN | HIS | Substantially Equivalent | Hollender Sustainable Brands, LLC | accessdata.fda.gov |
Compare with other makers
Updated September 7, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.