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Peripheral Blood Processing Device For Wound Management

Reapplix Aps

The following data is part of a premarket notification filed by Reapplix Aps 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: BK140211
• 510k Number: BK140211
• 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: Peripheral Blood Processing Device For Wound Management
• Applicant: Reapplix Aps blokken 45 Birkerod, 3460 DA
• Product Code: PMQ
• CFR Regulation Number: 864.9245 [🔎]
• Decision: Substantially Equivalent (SE)
• Type: 510(k) Traditio
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2014-12-29
• Decision Date: 2016-02-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05714188505619	BK140211	0
05714188502106	BK140211	0
05714188505008	BK140211	0
05714188505206	BK140211	0
05714188505503	BK140211	0
05714188505602	BK140211	0
05714188501093	BK140211	0
05714188502151	BK140211	0
05714188505046	BK140211	0
05714188505220	BK140211	0
05714188505541	BK140211	0
05714188501000	BK140211	0