The following data is part of a premarket notification filed by Healthcare Technologies, Inc. with the FDA for Uniport Models Sd-90, Td-60, Td-70 & Td-90.
Device ID | K873575 |
510k Number | K873575 |
Device Name: | UNIPORT MODELS SD-90, TD-60, TD-70 & TD-90 |
Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
Applicant | HEALTHCARE TECHNOLOGIES, INC. 3300 OAKTON ST. Skokie, IL 60076 |
Contact | Jeffrey A Mcintyre |
Correspondent | Jeffrey A Mcintyre HEALTHCARE TECHNOLOGIES, INC. 3300 OAKTON ST. Skokie, IL 60076 |
Product Code | LJT |
CFR Regulation Number | 880.5965 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-25 |
Decision Date | 1987-11-13 |