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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: BK170002
• 510k Number: BK170002
• 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: No
• Date Received: 2017-01-03
• Decision Date: 2017-04-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05714188308050	BK170002	0
05714188301822	BK170002	0
05714188021577	BK170002	0
05714188308067	BK170002	0
05714188308005	BK170002	0
05714188301808	BK170002	0