The following data is part of a premarket notification filed by Medcare Medical Group, Inc. with the FDA for Catheter Insertion Tray.
| Device ID | K962849 |
| 510k Number | K962849 |
| Device Name: | CATHETER INSERTION TRAY |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| 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 | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-22 |
| Decision Date | 1996-10-07 |
| Summary: | summary |