The following data is part of a premarket notification filed by Reckitt Benckiser Llc with the FDA for K-y Silicone.
| Device ID | K173504 |
| 510k Number | K173504 |
| Device Name: | K-Y Silicone |
| Classification | Lubricant, Personal |
| Applicant | Reckitt Benckiser LLC 399 Interpace Parkway Parsippany, NJ 07054 |
| Contact | Elizabeth Viguerie |
| Correspondent | Elizabeth Viguerie Reckitt Benckiser LLC 399 Interpace Parkway Parsippany, NJ 07054 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-13 |
| Decision Date | 2018-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10067981953975 | K173504 | 000 |
| 77067981953970 | K173504 | 000 |
| 77067981993747 | K173504 | 000 |
| 00067981941838 | K173504 | 000 |
| 00302340995580 | K173504 | 000 |
| 77302340995582 | K173504 | 000 |
| 10302340995587 | K173504 | 000 |
| 10067981993742 | K173504 | 000 |
| 20067981087899 | K173504 | 000 |
| 10067981096740 | K173504 | 000 |
| 10067981941835 | K173504 | 000 |
| 77067981096745 | K173504 | 000 |