The following data is part of a premarket notification filed by Paladin Medical, Inc. with the FDA for Core Prevent Mattress Modification.
| Device ID | K935220 |
| 510k Number | K935220 |
| Device Name: | CORE PREVENT MATTRESS MODIFICATION |
| Classification | Cover, Mattress (medical Purposes) |
| Applicant | PALADIN MEDICAL, INC. P.O. BOX 560 Stillwater, MN 55082 -0560 |
| Contact | Elaine Duncan |
| Correspondent | Elaine Duncan PALADIN MEDICAL, INC. P.O. BOX 560 Stillwater, MN 55082 -0560 |
| Product Code | FMW |
| CFR Regulation Number | 880.6190 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-12 |
| Decision Date | 1993-11-29 |