The following data is part of a premarket notification filed by Horizon Medical Products, Inc. with the FDA for Hmp Dual Polysulfone Port.
| Device ID | K934640 |
| 510k Number | K934640 |
| Device Name: | HMP DUAL POLYSULFONE PORT |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | HORIZON MEDICAL PRODUCTS, INC. 4200 NORTHSIDE PARKWAY N.W. Atlanta, GA 30327 |
| Contact | Roddy J H. Clark |
| Correspondent | Roddy J H. Clark HORIZON MEDICAL PRODUCTS, INC. 4200 NORTHSIDE PARKWAY N.W. Atlanta, GA 30327 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-28 |
| Decision Date | 1994-02-25 |