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Container, Frozen Donor Tissue Storage

Charter Medical, Ltd.

The following data is part of a premarket notification filed by Charter Medical, Ltd. with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration   Follow Fda En Español Search Fda   Home Food Drugs Medical Devices .

Pre-market Notification Details

• Device ID: BK100049
• 510k Number: BK100049
• Device Name: 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
• Classification: Container, Frozen Donor Tissue Storage
• Applicant: Charter Medical, Ltd. 3948-a Westpoint Blvd. Winston-salem, NC 27103
• Product Code: LPZ
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SE)
• Type: 510(k) Traditio
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-07-22
• Decision Date: 2010-12-07

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00817827023569	BK100049	0
00817827023552	BK100049	0
00817827025457	BK100049	0
00817827023538	BK100049	0
00817827023521	BK100049	0
00817827023514	BK100049	0