The following data is part of a premarket notification filed by Toro Management Llc Dba Sylk with the FDA for Sylk Personal Lubricant.
| Device ID | K152646 |
| 510k Number | K152646 |
| Device Name: | SYLK PERSONAL LUBRICANT |
| Classification | Lubricant, Personal |
| Applicant | TORO MANAGEMENT LLC DBA SYLK 7272 EAST INDIAN SCHOOL ROAD SUITE 540 Scottsdale, AZ 85251 |
| Contact | Mariessa Mahfouz |
| Correspondent | Jeff Morgan QPC SERVICES P O BOX 818 Ocean Shores, WA 98569 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-16 |
| Decision Date | 2016-03-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868371000209 | K152646 | 000 |
| 00851669008261 | K152646 | 000 |
| 00869521000353 | K152646 | 000 |