The following data is part of a premarket notification filed by Rb Health (us) Llc with the FDA for Ky Grosz Ultragel.
| Device ID | K192982 |
| 510k Number | K192982 |
| Device Name: | KY Grosz UltraGel |
| Classification | Lubricant, Personal |
| Applicant | RB Health (US) LLC 399 Interpace Parkway Parsippany, NJ 07054 |
| Contact | Elizabeth Viguerie |
| Correspondent | Elizabeth Viguerie RB Health (US) 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 | 2019-10-25 |
| Decision Date | 2020-04-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10067981088073 | K192982 | 000 |
| 99067981993756 | K192982 | 000 |