The following data is part of a premarket notification filed by Toaster Labs, Inc with the FDA for Pulse H20h!.
| Device ID | K152628 |
| 510k Number | K152628 |
| Device Name: | Pulse H20h! |
| Classification | Lubricant, Personal |
| Applicant | TOASTER LABS, INC 2212 QUEEN ANNE AVENUE NORTH, #269 Seattle, WA 98109 |
| Contact | Amy C. Buckalter |
| Correspondent | Amy C. Buckalter TOASTER LABS, INC 2212 QUEEN ANNE AVENUE NORTH, #269 Seattle, WA 98109 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-15 |
| Decision Date | 2016-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00867003000204 | K152628 | 000 |