The following data is part of a premarket notification filed by Charter Medical, Ltd. with the FDA for Transfer Sets.
| Device ID | BK050021 |
| 510k Number | BK050021 |
| Device Name: | Transfer Sets |
| Classification | Set, Transfer (blood/plasma) |
| Applicant | Charter Medical, Ltd. 3948-a Westpoint Blvd. Winston-salem, NC 27103 |
| Product Code | KSB |
| CFR Regulation Number | 864.9875 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-14 |
| Decision Date | 2005-07-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817827021855 | BK050021 | 0 |
| 00817827021039 | BK050021 | 0 |
| 00817827021749 | BK050021 | 0 |
| 00817827021756 | BK050021 | 0 |
| 00817827021565 | BK050021 | 0 |
| 00817827021572 | BK050021 | 0 |
| 00817827021589 | BK050021 | 0 |
| 00817827021596 | BK050021 | 0 |
| 00817827021107 | BK050021 | 0 |
| 00817827021619 | BK050021 | 0 |
| 00817827021626 | BK050021 | 0 |
| 00817827021633 | BK050021 | 0 |
| 00817827021640 | BK050021 | 0 |
| 00817827021725 | BK050021 | 0 |