The following data is part of a premarket notification filed by Healthcare Technologies, Inc. with the FDA for Uniport Model Sd-60, Sd-70.
Device ID | K870950 |
510k Number | K870950 |
Device Name: | UNIPORT MODEL SD-60, SD-70 |
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 | 1987-03-10 |
Decision Date | 1987-08-04 |