The following data is part of a premarket notification filed by Limerick, Inc. with the FDA for Pj.s Comfort Portable Electric Breast Pump.
| Device ID | K012275 |
| 510k Number | K012275 |
| Device Name: | PJ.S COMFORT PORTABLE ELECTRIC BREAST PUMP |
| Classification | Pump, Breast, Powered |
| Applicant | LIMERICK, INC. 903 NORTH SAN FERNANDO BLVD. SUITE 5 Burbank, CA 91504 |
| Contact | Patricia Kelly |
| Correspondent | Patricia Kelly LIMERICK, INC. 903 NORTH SAN FERNANDO BLVD. SUITE 5 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 | 2001-07-19 |
| Decision Date | 2002-01-07 |
| Summary: | summary |