The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Gel Cushion.
| Device ID | K941858 |
| 510k Number | K941858 |
| Device Name: | GEL CUSHION |
| Classification | Cushion, Flotation |
| Applicant | HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
| Contact | Joseph S Tokarz |
| Correspondent | Joseph S Tokarz HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
| Product Code | KIC |
| CFR Regulation Number | 890.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-15 |
| Decision Date | 1994-05-05 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() GEL CUSHION 97582532 not registered Live/Pending |
Yannan Huang 2022-09-08 |
![]() GEL CUSHION 76254361 not registered Dead/Abandoned |
Fitness Quest Inc. 2001-05-09 |