The following data is part of a premarket notification filed by Delphi Consulting Group with the FDA for Trinity Dvt System.
Device ID | K963957 |
510k Number | K963957 |
Device Name: | TRINITY DVT SYSTEM |
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 | 1996-10-02 |
Decision Date | 1997-11-04 |
Summary: | summary |