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 |