The following data is part of a premarket notification filed by Jobst A Beiersdorf Co. with the FDA for Jobst Athrombic Pump/sleeve.
| Device ID | K970922 |
| 510k Number | K970922 |
| Device Name: | JOBST ATHROMBIC PUMP/SLEEVE |
| Classification | Sleeve, Limb, Compressible |
| Applicant | JOBST A BEIERSDORF CO. 5825 CARNEGIE BLVD. Charlotte, NC 28209 -4633 |
| Contact | Angelo R Pereira |
| Correspondent | Angelo R Pereira JOBST A BEIERSDORF CO. 5825 CARNEGIE BLVD. Charlotte, NC 28209 -4633 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-12 |
| Decision Date | 1998-01-13 |
| Summary: | summary |