INTRAVASCULAR ADMINISTRATION SET

Set, Administration, Intravascular

Y

The following data is part of a premarket notification filed by Y with the FDA for Intravascular Administration Set.

Pre-market Notification Details

• Device ID: K820278
• 510k Number: K820278
• Device Name: INTRAVASCULAR ADMINISTRATION SET
• Classification: Set, Administration, Intravascular
• Applicant: Y 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: FPA
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1982-02-02
• Decision Date: 1982-02-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
40080196714934	K820278	000
50885403223141	K820278	000
50885403223462	K820278	000
50885403225848	K820278	000
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50885403221147	K820278	000
50885403221130	K820278	000
20080196760029	K820278	000
40884389959252	K820278	000
37613203010901	K820278	000
37613203010925	K820278	000
37613203010949	K820278	000
37613203010956	K820278	000
37613203020764	K820278	000
37613203020900	K820278	000
37613203020924	K820278	000
50885403199125	K820278	000
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50885403235342	K820278	000
50885403422391	K820278	000