The following data is part of a premarket notification filed by Compression Therapy Concepts, Inc. with the FDA for Vasopress Supreme Mini Model Vp500dm.
| Device ID | K101915 |
| 510k Number | K101915 |
| Device Name: | VASOPRESS SUPREME MINI MODEL VP500DM |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-09 |
| Decision Date | 2010-08-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20815245010271 | K101915 | 000 |
| 20815245010240 | K101915 | 000 |
| 20815245010080 | K101915 | 000 |