The following data is part of a premarket notification filed by Puronxy, Inc. with the FDA for Soothies Gel Pads.
| Device ID | K052858 |
| 510k Number | K052858 |
| Device Name: | SOOTHIES GEL PADS |
| Classification | Nursing Pad, Cohesive Gel |
| Applicant | PURONXY, INC. 9853 PACIFIC HEIGHTS BLVD. SUITE L San Diego, CA 92121 |
| Contact | Leslie Sebastain |
| Correspondent | Leslie Sebastain PURONXY, INC. 9853 PACIFIC HEIGHTS BLVD. SUITE L San Diego, CA 92121 |
| Product Code | NXH |
| CFR Regulation Number | 880.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-11 |
| Decision Date | 2006-02-09 |
| Summary: | summary |