The following data is part of a premarket notification filed by Pa Medical Corp. with the FDA for Oncology Spt Sys #ms-c10 Medication Reservoir Bag.
| Device ID | K871449 |
| 510k Number | K871449 |
| Device Name: | ONCOLOGY SPT SYS #MS-C10 MEDICATION RESERVOIR BAG |
| Classification | Container, I.v. |
| Applicant | PA MEDICAL CORP. 1512 NASHVILLE HIGHWAY P.O. BOX 1286 Columbia, TN 38401 |
| Contact | Bailey Vaughn |
| Correspondent | Bailey Vaughn PA MEDICAL CORP. 1512 NASHVILLE HIGHWAY P.O. BOX 1286 Columbia, TN 38401 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-13 |
| Decision Date | 1987-06-17 |