The following data is part of a premarket notification filed by D.a. Schulman, Inc. with the FDA for Safe-seat, Low-profile Wheelchair Cushion.
Device ID | K872739 |
510k Number | K872739 |
Device Name: | SAFE-SEAT, LOW-PROFILE WHEELCHAIR CUSHION |
Classification | Cushion, Flotation |
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 | KIC |
CFR Regulation Number | 890.3175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-09 |
Decision Date | 1987-07-30 |