The following data is part of a premarket notification filed by Ohio Medical Instrument Co., Inc. with the FDA for Cuddle Up Pillow.
| Device ID | K882544 |
| 510k Number | K882544 |
| Device Name: | CUDDLE UP PILLOW |
| Classification | Holder, Infant Position |
| Applicant | OHIO MEDICAL INSTRUMENT CO., INC. 3924 VIRGINIA AVE. Cincinnati, OH 45227 |
| Contact | Cynthia B Sibrel |
| Correspondent | Cynthia B Sibrel OHIO MEDICAL INSTRUMENT CO., INC. 3924 VIRGINIA AVE. Cincinnati, OH 45227 |
| Product Code | FRP |
| CFR Regulation Number | 880.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-21 |
| Decision Date | 1989-01-31 |