The following data is part of a premarket notification filed by Perrigo New York, Inc. with the FDA for Personal Lubricating Jelly.
| Device ID | K180923 |
| 510k Number | K180923 |
| Device Name: | Personal Lubricating Jelly |
| Classification | Lubricant, Personal |
| Applicant | Perrigo New York, Inc. 1700 Bathgate Ave. Bronx, NY 10457 -7512 |
| Contact | Karen Dombrowski |
| Correspondent | Phil Triolo Phil Triolo And Associates LC 86 Skycrest Land Salt Lake City, UT 84108 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-09 |
| Decision Date | 2018-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10041220823229 | K180923 | 000 |
| 10719283168341 | K180923 | 000 |
| 03700301471826 | K180923 | 000 |
| 10311917206551 | K180923 | 000 |
| 20041220706253 | K180923 | 000 |
| 10041415055756 | K180923 | 000 |
| 10041163250922 | K180923 | 000 |
| 00070030147655 | K180923 | 000 |
| 00041520314307 | K180923 | 000 |