The following data is part of a premarket notification filed by Midwest Reprocessing Center Llc with the FDA for Midwest Reprocessing Center Reprocessed Venodyne Sleeves/foot Cuffs.
| Device ID | K101702 |
| 510k Number | K101702 |
| Device Name: | MIDWEST REPROCESSING CENTER REPROCESSED VENODYNE SLEEVES/FOOT CUFFS |
| Classification | Sleeve, Limb, Compressible |
| Applicant | MIDWEST REPROCESSING CENTER LLC 434 INDUSTRIAL LANE Birmingham, AL 35211 |
| Contact | Jerome James |
| Correspondent | Jerome James MIDWEST REPROCESSING CENTER LLC 434 INDUSTRIAL LANE Birmingham, AL 35211 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-17 |
| Decision Date | 2010-08-27 |
| Summary: | summary |