The following data is part of a premarket notification filed by Chartermed, Inc. with the FDA for Empty Containers For The Collection & Processing Of Blood/blood Components.
Device ID | BK960043 |
510k Number | BK960043 |
Device Name: | Empty Containers For The Collection & Processing Of Blood/Blood Components |
Classification | Container, Empty, For Collection & Processing Of Blood & Blood Components |
Applicant | CharterMed, Inc. 3948-a West Point Blvd. Winston-salem, NC 27103 |
Product Code | KSR |
CFR Regulation Number | 864.9100 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-04-11 |
Decision Date | 1996-09-11 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00817827025792 | BK960043 | 0 |
00817827025631 | BK960043 | 0 |
00817827025624 | BK960043 | 0 |
00817827025617 | BK960043 | 0 |
00817827025600 | BK960043 | 0 |
00817827025594 | BK960043 | 0 |
00817827025587 | BK960043 | 0 |
00817827025570 | BK960043 | 0 |
00817827025563 | BK960043 | 0 |
00817827025556 | BK960043 | 0 |
00817827025549 | BK960043 | 0 |
00817827025532 | BK960043 | 0 |
00817827025525 | BK960043 | 0 |
00817827025648 | BK960043 | 0 |
00817827025655 | BK960043 | 0 |
00817827025662 | BK960043 | 0 |
00817827025785 | BK960043 | 0 |
00817827025778 | BK960043 | 0 |
00817827025761 | BK960043 | 0 |
00817827025754 | BK960043 | 0 |
00817827025747 | BK960043 | 0 |
00817827025730 | BK960043 | 0 |
00817827025723 | BK960043 | 0 |
00817827025716 | BK960043 | 0 |
00817827025709 | BK960043 | 0 |
00817827025693 | BK960043 | 0 |
00817827025686 | BK960043 | 0 |
00817827025679 | BK960043 | 0 |
00817827025518 | BK960043 | 0 |