The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Suction Catheter Kit, Sterile, Single-use.
| Device ID | K951506 |
| 510k Number | K951506 |
| Device Name: | SUCTION CATHETER KIT, STERILE, SINGLE-USE |
| Classification | Catheters, Suction, Tracheobronchial |
| 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 | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-03 |
| Decision Date | 1995-07-03 |