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 |