The following data is part of a premarket notification filed by Horizon Medical Products, Inc. with the FDA for Hmp Dual Titanium Port.
Device ID | K934504 |
510k Number | K934504 |
Device Name: | HMP DUAL TITANIUM 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 | 1993-09-15 |
Decision Date | 1994-02-25 |