The following data is part of a premarket notification filed by Medical Components Inc with the FDA for Split Cath Iii 24cm Split Cath Iii 24cm Split Cath Iii 32cm Cath Iii 36cm Split Cath Iii 40cm And 55cm.
| Device ID | K121848 |
| 510k Number | K121848 |
| Device Name: | SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | MEDICAL COMPONENTS INC 1499 DELP DRIVE Harleysville, PA 19438 |
| Contact | Jean Callow |
| Correspondent | Jean Callow MEDICAL COMPONENTS INC 1499 DELP DRIVE Harleysville, PA 19438 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-25 |
| Decision Date | 2012-09-21 |