The following data is part of a premarket notification filed by Compression Therapy Concepts, Inc. with the FDA for Ctc Dvt-1 Calf Garment, Model Dvt-1.
| Device ID | K000147 |
| 510k Number | K000147 |
| Device Name: | CTC DVT-1 CALF GARMENT, MODEL DVT-1 |
| Classification | Sleeve, Limb, Compressible |
| Applicant | COMPRESSION THERAPY CONCEPTS, INC. 3614 KENNEDY RD. South Plainfield, NJ 07080 |
| Contact | J. James Britton |
| Correspondent | J. James Britton COMPRESSION THERAPY CONCEPTS, INC. 3614 KENNEDY RD. South Plainfield, NJ 07080 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-18 |
| Decision Date | 2000-04-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40815245011364 | K000147 | 000 |
| 40815245010329 | K000147 | 000 |
| 40815245010374 | K000147 | 000 |
| 40815245010428 | K000147 | 000 |
| 40815245010473 | K000147 | 000 |
| 40815245010824 | K000147 | 000 |
| 40815245010879 | K000147 | 000 |
| 40815245010923 | K000147 | 000 |
| 40815245010978 | K000147 | 000 |
| 20815245010028 | K000147 | 000 |