Empty Containers For The Collection & Processing Of Blood/Blood Components

Container, Empty, For Collection & Processing Of Blood & Blood Components

CharterMed, Inc.

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.

Pre-market Notification Details

Device IDBK960043
510k NumberBK960043
Device Name:Empty Containers For The Collection & Processing Of Blood/Blood Components
ClassificationContainer, Empty, For Collection & Processing Of Blood & Blood Components
Applicant CharterMed, Inc. 3948-a West Point Blvd. Winston-salem,  NC  27103
Product CodeKSR  
CFR Regulation Number864.9100 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-04-11
Decision Date1996-09-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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

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