The following data is part of a premarket notification filed by Medical Components, Inc. with the FDA for Mcscp8ps With 'y' Hub.
| Device ID | K821684 |
| 510k Number | K821684 |
| Device Name: | MCSCP8PS WITH 'Y' HUB |
| Classification | Catheter, Subclavian |
| Applicant | MEDICAL COMPONENTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LFJ |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-08 |
| Decision Date | 1982-06-24 |