BAG DECANTER

Container, I.v.

ADVANCE MEDICAL DESIGNS, INC.

The following data is part of a premarket notification filed by Advance Medical Designs, Inc. with the FDA for Bag Decanter.

Pre-market Notification Details

• Device ID: K852777
• 510k Number: K852777
• Device Name: BAG DECANTER
• Classification: Container, I.v.
• Applicant: ADVANCE MEDICAL DESIGNS, INC. 1400 MARIETTA PARKWAY, SU 105 Marietta, GA 30067
• Contact: Joseph R Cottone
• Correspondent: Joseph R Cottone; ADVANCE MEDICAL DESIGNS, INC. 1400 MARIETTA PARKWAY, SU 105 Marietta, GA 30067
• Product Code: KPE
• CFR Regulation Number: 880.5025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-07-01
• Decision Date: 1985-08-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10888277006263	K852777	000
10888277006256	K852777	000