The following data is part of a premarket notification filed by Healthpak, Inc. with the FDA for Health Pak Tray Sox Barriers.
| Device ID | K920052 |
| 510k Number | K920052 |
| Device Name: | HEALTH PAK TRAY SOX BARRIERS |
| Classification | Drape, Surgical |
| Applicant | HEALTHPAK, INC. 227 WEST MONROE ST. 49TH FLOOR Chicago, IL 60606 |
| Contact | Dennis M Gronek |
| Correspondent | Dennis M Gronek HEALTHPAK, INC. 227 WEST MONROE ST. 49TH FLOOR Chicago, IL 60606 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-06 |
| Decision Date | 1992-04-03 |