The following data is part of a premarket notification filed by Compression Therapy Concepts, Inc. with the FDA for Vasopress Reprocessed Dvt Leg / Foot Garments.
| Device ID | K112838 |
| 510k Number | K112838 |
| Device Name: | VASOPRESS REPROCESSED DVT LEG / FOOT GARMENTS |
| Classification | Sleeve, Limb, Compressible |
| Applicant | COMPRESSION THERAPY CONCEPTS, INC. 35 JAMES WAY Eatontown, NJ 07724 |
| Contact | Leonard Nass |
| Correspondent | Leonard Nass COMPRESSION THERAPY CONCEPTS, INC. 35 JAMES WAY Eatontown, NJ 07724 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-28 |
| Decision Date | 2011-11-10 |
| Summary: | summary |