The following data is part of a premarket notification filed by Perfect Fit Industries, Inc. with the FDA for Wipeable Pillow.
| Device ID | K924477 |
| 510k Number | K924477 |
| Device Name: | WIPEABLE PILLOW |
| Classification | Cover, Mattress (medical Purposes) |
| Applicant | PERFECT FIT INDUSTRIES, INC. 3300 NCNB PLAZA Charlotte, NC 28280 |
| Contact | Brian C Reeve |
| Correspondent | Brian C Reeve PERFECT FIT INDUSTRIES, INC. 3300 NCNB PLAZA Charlotte, NC 28280 |
| Product Code | FMW |
| CFR Regulation Number | 880.6190 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-03 |
| Decision Date | 1993-01-29 |