The following data is part of a premarket notification filed by Healthpak, Inc. with the FDA for Healthpak Chair Sox Barriers.
| Device ID | K922175 |
| 510k Number | K922175 |
| Device Name: | HEALTHPAK CHAIR SOX BARRIERS |
| Classification | Chair, Dental, With Operative Unit |
| 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 | KLC |
| CFR Regulation Number | 872.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-08 |
| Decision Date | 1992-08-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H816DC0115S2 | K922175 | 000 |
| H816BB2930C2 | K922175 | 000 |
| H816BB0528X2 | K922175 | 000 |
| H816BB0312H2 | K922175 | 000 |
| H816MDC0115S2 | K922175 | 000 |
| H816MBB2930C2 | K922175 | 000 |
| H816MBB0528X2 | K922175 | 000 |
| H816MBB0312H2 | K922175 | 000 |