The following data is part of a premarket notification filed by Medcare Medical Group, Inc. with the FDA for Huberloc.
| Device ID | K973497 |
| 510k Number | K973497 |
| Device Name: | HUBERLOC |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | MEDCARE MEDICAL GROUP, INC. 234 OLD HOMESTEAD HWY. East Swanzey, NH 03446 |
| Contact | Craig J Bell |
| Correspondent | Craig J Bell MEDCARE MEDICAL GROUP, INC. 234 OLD HOMESTEAD HWY. East Swanzey, NH 03446 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-15 |
| Decision Date | 1998-01-13 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() HUBERLOC 76023256 2629899 Dead/Cancelled |
MEDCARE MEDICAL GROUP, INC. 2000-04-11 |