The following data is part of a premarket notification filed by Fiberoptic Medical Products, Inc. with the FDA for Wallaby(tm) Blanket.
| Device ID | K883779 |
| 510k Number | K883779 |
| Device Name: | WALLABY(TM) BLANKET |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | FIBEROPTIC MEDICAL PRODUCTS, INC. 3400 CENTRE SQUARE WEST 1500 MARKET STREET Philadelphia, PA 19102 |
| Contact | John B Reiss |
| Correspondent | John B Reiss FIBEROPTIC MEDICAL PRODUCTS, INC. 3400 CENTRE SQUARE WEST 1500 MARKET STREET Philadelphia, PA 19102 |
| Product Code | LBI |
| CFR Regulation Number | 880.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-06 |
| Decision Date | 1988-11-14 |