The following data is part of a premarket notification filed by Premie Comfort Products with the FDA for Premie Comfort Pad Patient & Infant Support Pads.
| Device ID | K844176 |
| 510k Number | K844176 |
| Device Name: | PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS |
| Classification | Holder, Infant Position |
| Applicant | PREMIE COMFORT PRODUCTS 3745 PURDUE ST. Dallas, TX 75225 |
| Contact | Margaret A Sinclair |
| Correspondent | Margaret A Sinclair PREMIE COMFORT PRODUCTS 3745 PURDUE ST. Dallas, TX 75225 |
| Product Code | FRP |
| CFR Regulation Number | 880.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-25 |
| Decision Date | 1985-01-23 |