The following data is part of a premarket notification filed by Tri-state Hospital Supply Corp. with the FDA for Centlurion Disp Steri Dental/hygiene Pack/trays.
| Device ID | K931748 |
| 510k Number | K931748 |
| Device Name: | CENTLURION DISP STERI DENTAL/HYGIENE PACK/TRAYS |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | TRI-STATE HOSPITAL SUPPLY CORP. 301 CATRELL DR. P.O. BOX 170 Howell, MI 48843 |
| Contact | George J Pluta |
| Correspondent | George J Pluta TRI-STATE HOSPITAL SUPPLY CORP. 301 CATRELL DR. P.O. BOX 170 Howell, MI 48843 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-08 |
| Decision Date | 1994-02-25 |