The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Sterile V.a.d. (vascular Access Devices) Access Kit, Disposable.
| Device ID | K952058 |
| 510k Number | K952058 |
| Device Name: | STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | TRINITY LABORATORIES, INC. 201 KILEY DR. P.O. BOX 1818 Salisbury, MD 21802 |
| Contact | Partha Basumallik |
| Correspondent | Partha Basumallik TRINITY LABORATORIES, INC. 201 KILEY DR. P.O. BOX 1818 Salisbury, MD 21802 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-02 |
| Decision Date | 1995-09-21 |