MODIFIED LABELING FOR AMUKIN-50%

Set, Administration, For Peritoneal Dialysis, Disposable

AMUCHINA INTL., INC.

The following data is part of a premarket notification filed by Amuchina Intl., Inc. with the FDA for Modified Labeling For Amukin-50%.

Pre-market Notification Details

• Device ID: K871583
• 510k Number: K871583
• Device Name: MODIFIED LABELING FOR AMUKIN-50%
• Classification: Set, Administration, For Peritoneal Dialysis, Disposable
• Applicant: AMUCHINA INTL., INC. 12120A HERITAGE PARK CIRCLE Silver Spring, MD 20906
• Contact: Cooney, Pa
• Correspondent: Cooney, Pa; AMUCHINA INTL., INC. 12120A HERITAGE PARK CIRCLE Silver Spring, MD 20906
• Product Code: KDJ
• CFR Regulation Number: 876.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1987-04-23
• Decision Date: 1987-07-09

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20898021000055	K871583	000
00898021000044	K871583	000