The following data is part of a premarket notification filed by Physician Engineered Products, Inc. with the FDA for Retrofit Baby Face Shield (rfs).
| Device ID | K882291 |
| 510k Number | K882291 |
| Device Name: | RETROFIT BABY FACE SHIELD (RFS) |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | PHYSICIAN ENGINEERED PRODUCTS, INC. HCO6 BOX 17 Park Rapids, MN 56470 |
| Contact | Rose, M.d. |
| Correspondent | Rose, M.d. PHYSICIAN ENGINEERED PRODUCTS, INC. HCO6 BOX 17 Park Rapids, MN 56470 |
| Product Code | LBI |
| CFR Regulation Number | 880.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-01 |
| Decision Date | 1988-06-20 |