The following data is part of a premarket notification filed by D.a. Schulman, Inc. with the FDA for Swell-relief.
| Device ID | K855004 |
| 510k Number | K855004 |
| Device Name: | SWELL-RELIEF |
| Classification | Compressor, Cardiac, External |
| Applicant | D.A. SCHULMAN, INC. 7701 NEWTON AVE NORTH Brooklyn Park, MN 55444 |
| Contact | David A Schulman |
| Correspondent | David A Schulman D.A. SCHULMAN, INC. 7701 NEWTON AVE NORTH Brooklyn Park, MN 55444 |
| Product Code | DRM |
| CFR Regulation Number | 870.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-13 |
| Decision Date | 1986-02-12 |