The following data is part of a premarket notification filed by Limerick, Inc. with the FDA for Pj's Serenity.
| Device ID | K132220 |
| 510k Number | K132220 |
| Device Name: | PJ'S SERENITY |
| Classification | Pump, Breast, Powered |
| Applicant | LIMERICK, INC. 2150 N. GLENOAKS BLVD. Burbank, CA 91504 |
| Contact | Patricia Kelly |
| Correspondent | Patricia Kelly LIMERICK, INC. 2150 N. GLENOAKS BLVD. Burbank, CA 91504 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-17 |
| Decision Date | 2015-02-20 |
| Summary: | summary |