The following data is part of a premarket notification filed by Geen Healthcare, Inc. with the FDA for Geen Medisox.
| Device ID | K981296 |
| 510k Number | K981296 |
| Device Name: | GEEN MEDISOX |
| Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
| Applicant | GEEN HEALTHCARE, INC. 931 PROGRESS AVE., UNIT 13 Scarborough, Ontario, CA M1g 3v5 |
| Contact | Greg W Geen |
| Correspondent | Greg W Geen GEEN HEALTHCARE, INC. 931 PROGRESS AVE., UNIT 13 Scarborough, Ontario, CA M1g 3v5 |
| Product Code | DWL |
| CFR Regulation Number | 880.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-09 |
| Decision Date | 1998-05-29 |
| Summary: | summary |