The following data is part of a premarket notification filed by Ttk Protective Devices Limited (formerly Ttk-lig L with the FDA for Skore And Multiple Brands.
| Device ID | K132490 |
| 510k Number | K132490 |
| Device Name: | SKORE AND MULTIPLE BRANDS |
| Classification | Condom |
| Applicant | TTK PROTECTIVE DEVICES LIMITED (FORMERLY TTK-LIG L 2871, COASTAL DR Aurora, IL 60503 |
| Contact | Manoj Zacharias |
| Correspondent | Manoj Zacharias TTK PROTECTIVE DEVICES LIMITED (FORMERLY TTK-LIG L 2871, COASTAL DR Aurora, IL 60503 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-08 |
| Decision Date | 2014-10-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08906007135849 | K132490 | 000 |
| 08906007135801 | K132490 | 000 |
| 08906007135764 | K132490 | 000 |