The following data is part of a premarket notification filed by Delphi Consulting Group with the FDA for Trinity Ii Single Chamber Dvt Pump.
| Device ID | K983680 |
| 510k Number | K983680 |
| Device Name: | TRINITY II SINGLE CHAMBER DVT PUMP |
| Classification | Sleeve, Limb, Compressible |
| Applicant | DELPHI CONSULTING GROUP 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
| Contact | J. Harvey Knauss |
| Correspondent | J. Harvey Knauss DELPHI CONSULTING GROUP 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-20 |
| Decision Date | 1999-04-28 |
| Summary: | summary |