The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Catheterization Insertion Pack Urological, Sterile, Disposable.
| Device ID | K951479 |
| 510k Number | K951479 |
| Device Name: | CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE |
| Classification | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) |
| Applicant | TRINITY LABORATORIES, INC. 201 KILEY DR. P.O. BOX 1818 Salisbury, MD 21802 |
| Contact | B Asumallik |
| Correspondent | B Asumallik TRINITY LABORATORIES, INC. 201 KILEY DR. P.O. BOX 1818 Salisbury, MD 21802 |
| Product Code | FCM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-30 |
| Decision Date | 1995-06-15 |